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	<title>Clinical Technologies</title>
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		<title>Data Quality and Monitoring in Clinical Trials: Reducing Errors and Ensuring Compliance </title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/data-quality-and-monitoring-in-clinical-trials-reducing-errors-and-ensuring-compliance/</link>
		
		<dc:creator><![CDATA[chloefinch]]></dc:creator>
		<pubDate>Tue, 24 Feb 2026 08:43:33 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=6721</guid>

					<description><![CDATA[<p>Capturing usable source data is one of the most critical aspects of a clinical trial.&#160;With the global reach of many&#160;clinical trials,&#160;clinical sites&#160;can face unique challenges in ensuring the data is&#160;accurate, consistent, and&#160;fit&#160;for its intended&#160;use.&#160;Leveraging the right&#160;technology helps&#160;site users&#160;capture,&#160;validate, and aggregate&#160;trial data&#160;more effectively, offering clear advantages over manual processes.&#160;&#160; This article illustrates how tailored reporting solutions [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/data-quality-and-monitoring-in-clinical-trials-reducing-errors-and-ensuring-compliance/">Data Quality and Monitoring in Clinical Trials: Reducing Errors and Ensuring Compliance </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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						<p><strong> Rich Wzorek</strong>, <em>Director | New Products &amp; Services | Almac Clinical Technologies</em></p>
<p><strong>Mark Dickinson</strong>, <em>Technical Manager| New Products &amp; Services | Almac Clinical Technologies</em></p>
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<p>Capturing usable source data is one of the most critical aspects of a clinical trial.&nbsp;With the global reach of many&nbsp;clinical trials,&nbsp;clinical sites&nbsp;can face unique challenges in ensuring the data is&nbsp;accurate, consistent, and&nbsp;fit&nbsp;for its intended&nbsp;use.&nbsp;Leveraging the right&nbsp;technology helps&nbsp;site users&nbsp;capture,&nbsp;validate, and aggregate&nbsp;trial data&nbsp;more effectively, offering clear advantages over manual processes.&nbsp;&nbsp;</p>



<p>This article illustrates how tailored reporting solutions address the unique requirements of different data sets, ensuring both regulatory compliance and operational efficiency.&nbsp;</p>



<p><strong>Technology&#8217;s Role</strong>&nbsp;</p>



<p>Given the sheer volume of transactions&nbsp;that&nbsp;create&nbsp;meaningful data throughout a clinical&nbsp;trial’s&nbsp;duration, manually&nbsp;validating,&nbsp;analysing,&nbsp;and aggregating this data would&nbsp;require&nbsp;large-scale&nbsp;execution of manual procedures.&nbsp;Ensuring compliance with&nbsp;these&nbsp;high-risk&nbsp;manual processes&nbsp;requires&nbsp;documented&nbsp;training and&nbsp;ongoing&nbsp;monitoring.&nbsp;&nbsp;</p>



<p>By entering&nbsp;transactions&nbsp;into&nbsp;validated&nbsp;systems that not only&nbsp;integrate but&nbsp;also&nbsp;interact with each other,&nbsp;the need for&nbsp;widespread&nbsp;manual&nbsp;processes&nbsp;is significantly reduced.&nbsp;Manual&nbsp;processes have their place but should be&nbsp;the exception,&nbsp;not the norm.&nbsp;</p>



<p>The data&nbsp;required&nbsp;for a clinical trial is very often&nbsp;just&nbsp;a small subset of what the site requires to provide the participant with the standard of care they deserve. This often has site users&nbsp;frequently&nbsp;switching&nbsp;between&nbsp;multiple&nbsp;systems,&nbsp;many of&nbsp;which&nbsp;are often not connected and require a certain level of manual transcription between systems.&nbsp;&nbsp;This can lead to data quality issues at worst,&nbsp;and&nbsp;a high&nbsp;volume of&nbsp;queries and discrepancies at best.&nbsp;</p>



<p>For example, if&nbsp;a site user&nbsp;transcribes&nbsp;lab values incorrectly,&nbsp;it could&nbsp;lead to&nbsp;erroneous&nbsp;dosing calculations and potentially even&nbsp;provide the incorrect dosage to&nbsp;a patient.&nbsp;In contrast, using technology to&nbsp;copy lab values from one system to another&nbsp;greatly reduces&nbsp;the likelihood of human error.&nbsp;</p>



<p><strong>Data Ownership</strong>&nbsp;</p>



<p>Given&nbsp;the need for multiple systems&nbsp;and&nbsp;different types&nbsp;of data,&nbsp;it is important to&nbsp;analyse&nbsp;not only the&nbsp;data&nbsp;itself but also how other systems&nbsp;utilise&nbsp;the information.&nbsp;Take, for example,&nbsp;a&nbsp;subject being screened at a site.&nbsp;In isolation,&nbsp;it&#8217;s&nbsp;a&nbsp;seemingly&nbsp;straightforward&nbsp;activity to record, but&nbsp;this single event&nbsp;can have a myriad of downstream impacts&nbsp;across the clinical trial. Here are some considerations:&nbsp;</p>



<ul class="wp-block-list">
<li>Who&nbsp;is responsible for&nbsp;data stewardship to ensure that the data is attributable,&nbsp;timely, and&nbsp;accurate?&nbsp;</li>
</ul>



<ul class="wp-block-list">
<li>Which system &#8220;owns&#8221; that&nbsp;screening&nbsp;data&nbsp;and&nbsp;can be considered the &#8220;source of truth&#8221;?&nbsp;&nbsp;</li>
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<li>How&nbsp;and where in the workflow&nbsp;will the data be&nbsp;validated?&nbsp;</li>
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<li>How should that&nbsp;newly screened subject&nbsp;reflect in&nbsp;dashboards, reports, and&nbsp;webpages&nbsp;used&nbsp;by site users?&nbsp;</li>
</ul>



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<li>Which other systems care about the subject being screened?&nbsp;</li>
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<p>The answers to these questions can help guide how data should be stored and how other systems can&nbsp;expect to&nbsp;receive that data.&nbsp;&nbsp;&nbsp;</p>



<p>When designing a&nbsp;system, proper&nbsp;data validation&nbsp;requirements&nbsp;are essential&nbsp;for&nbsp;maintaining&nbsp;consistency&nbsp;and quality.&nbsp;&nbsp;These&nbsp;validations also&nbsp;enable&nbsp;sites&nbsp;to conduct&nbsp;more&nbsp;effective analysis of datasets&nbsp;which&nbsp;can&nbsp;encompass multiple trials or&nbsp;even&nbsp;entire&nbsp;clinical trial&nbsp;portfolios.&nbsp;Furthermore, restricting non-source systems from&nbsp;modifying&nbsp;source&nbsp;data helps&nbsp;maintain&nbsp;data integrity and simplifies the process of reconciling data during key milestones such as interim analysis and database&nbsp;lock.&nbsp;</p>



<p><strong>Reporting</strong>&nbsp;</p>



<p>To achieve&nbsp;optimal&nbsp;outcomes,&nbsp;it’s&nbsp;crucial to design solutions that address specific reporting needs. Purpose-built tools streamline workflows and deliver precise answers,&nbsp;minimising&nbsp;manual&nbsp;intervention&nbsp;and reducing errors. Conversely, generic solutions often demand more manual effort and&nbsp;additional&nbsp;validation steps, increasing the risk of mistakes and inefficiencies.&nbsp;</p>



<p>Reporting on a trial’s data illustrates this principle in practice. Clinical sites often rely on exports or&nbsp;visualisations&nbsp;that pull information from multiple&nbsp;systems and&nbsp;combining that data accurately is essential to producing reports that satisfy both regulatory requirements and site‑level needs. When reporting tools are designed specifically for these nuanced use cases, they can apply the right logic for each dataset and reduce the need for manual reconciliation. In contrast, presenting all data in a uniform,&nbsp;generalised&nbsp;format may appear simpler at first glance but often leads to more exceptions, more back‑and‑forth validation, and a greater burden on site users to resolve inconsistencies.&nbsp;</p>



<p><strong>Best Practices for Data&nbsp;Utilisation&nbsp;in Clinical Trials</strong>&nbsp;</p>



<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><td><strong>Intended use of report</strong>&nbsp;</td><td><strong>Sample&nbsp;dataset size</strong>&nbsp;</td><td><strong>Utilisation&nbsp;of data</strong>&nbsp;</td></tr><tr><td>Upcoming patient visits&nbsp;</td><td>1000 rows&nbsp;</td><td>Viewable/actionable&nbsp;on web&nbsp;app&nbsp;</td></tr><tr><td>Current&nbsp;depot&nbsp;inventory&nbsp;</td><td>100000 rows&nbsp;</td><td>Exportable to Excel&nbsp;for further analysis&nbsp;</td></tr><tr><td>Quarterly audit trail of&nbsp;all site-related events&nbsp;</td><td>1M+ rows&nbsp;</td><td>Full-scale data transfer&nbsp;</td></tr></tbody></table></figure>



<p></p>



<p>As&nbsp;shown above, the intended use,&nbsp;dataset size, and&nbsp;other&nbsp;problem-specific&nbsp;requirements&nbsp;can vary&nbsp;significantly across&nbsp;different types&nbsp;of&nbsp;site-level&nbsp;information.&nbsp;&nbsp;For instance, the&nbsp;count&nbsp;of quarterly events in an audit trail&nbsp;export&nbsp;is&nbsp;distinctly&nbsp;larger than an export of&nbsp;upcoming patient&nbsp;visits.&nbsp;&nbsp;A&nbsp;system&nbsp;not&nbsp;explicitly&nbsp;designed to&nbsp;handle the&nbsp;unique needs&nbsp;of&nbsp;each&nbsp;dataset&nbsp;could very easily result in&nbsp;an improperly&nbsp;sized and inefficient&nbsp;generalised&nbsp;solution.&nbsp;Purpose-built reporting tools tailored to&nbsp;each scenario will&nbsp;be more effective in&nbsp;delivering the&nbsp;desired&nbsp;business outcomes.&nbsp;</p>



<p><strong>Conclusion</strong>&nbsp;</p>



<p>In summary,&nbsp;effective&nbsp;use of technology can have very tangible benefits&nbsp;in the all-important goal of capturing&nbsp;accurate&nbsp;and usable data during the lifespan of a clinical trial.&nbsp;Strong data ownership,&nbsp;stewardship,&nbsp;and&nbsp;validation&nbsp;practices&nbsp;are&nbsp;essential to&nbsp;maintaining&nbsp;data quality, and&nbsp;right-sizing solutions to process&nbsp;well-defined categories of information ensure that&nbsp;the&nbsp;data&nbsp;remains&nbsp;fit&nbsp;for its intended purposes, supporting both regulatory&nbsp;compliance&nbsp;and operational efficiency.&nbsp;</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/data-quality-and-monitoring-in-clinical-trials-reducing-errors-and-ensuring-compliance/">Data Quality and Monitoring in Clinical Trials: Reducing Errors and Ensuring Compliance </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Post SCOPE: Expert Insights and Predictions for the rest of 2026 </title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/post-scope-expert-insights-and-predictions-for-the-rest-of-2026/</link>
		
		<dc:creator><![CDATA[chloefinch]]></dc:creator>
		<pubDate>Thu, 12 Feb 2026 09:00:00 +0000</pubDate>
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		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=6793</guid>

					<description><![CDATA[<p>Over the past decade,&#160;clinical research has undergone one of the most profound technological transformations in its history.&#160;Legacy&#160;digital systems and point solutions have&#160;evolved into&#160;today’s landscape of&#160;integrated platforms, advanced analytics, decentralised execution, and early applications of artificial intelligence (AI).&#160;Looking ahead, the pace of innovation&#160;will continue, but with greater emphasis on&#160;efficiency, interoperability, regulatory alignment, and pragmatic value creation.&#160; [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/post-scope-expert-insights-and-predictions-for-the-rest-of-2026/">Post SCOPE: Expert Insights and Predictions for the rest of 2026 </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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						<p><strong> Duncan McDonald</strong>, <em>eClinical Solutions Advisor | Almac Clinical Technologies</em></p>
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<p>Over the past decade,&nbsp;clinical research has undergone one of the most profound technological transformations in its history.&nbsp;Legacy&nbsp;digital systems and point solutions have&nbsp;evolved into&nbsp;today’s landscape of&nbsp;integrated platforms, advanced analytics, decentralised execution, and early applications of artificial intelligence (AI).&nbsp;Looking ahead, the pace of innovation&nbsp;will continue, but with greater emphasis on&nbsp;<em>efficiency, interoperability, regulatory alignment, and pragmatic value creation</em>.&nbsp;</p>



<p>In this commentary, we highlight four defining trends that will shape clinical technologies in 2026 and beyond. These&nbsp;trends&nbsp;reflect&nbsp;where the industry is&nbsp;<em>today</em>, where&nbsp;it’s&nbsp;<em>rapidly headed</em>, and the governance frameworks that will ensure these advances drive better outcomes for patients and sponsors alike.&nbsp;</p>



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<h4 class="wp-block-heading" id="h-ai-enters-the-mainstream-from-novelty-to-operational-imperative-nbsp">AI Enters the Mainstream: From Novelty to Operational Imperative&nbsp;</h4>



<p>Artificial intelligence has shifted from conceptual promise to operational reality in many areas of clinical research. Today, AI is being used to optimise trial design, accelerate site feasibility analysis, personalise patient recruitment strategies, and enhance data cleaning and monitoring workflows. What was once experimental is now increasingly embedded within day-to-day operations.&nbsp;</p>



<p>However, as AI becomes more mainstream, it is essential to recognise that its integration must be guided by responsibility, accountability, and&nbsp;above all, ethical&nbsp;principles. The benefits of AI can only be fully realised when its use is not only transparent and&nbsp;validated, but also firmly rooted in ethical standards that protect patient rights, ensure data privacy, and promote fairness. Every application of AI should be subject to rigorous ethical review, with clear safeguards to prevent bias, misuse, or unintended consequences.&nbsp;</p>



<p>Regulators are responding in parallel: the U.S. Food and Drug Administration (FDA) has issued guidance emphasising a risk-based approach to AI credibility and validation, while the European Medicines Agency (EMA) continues to expand its use of AI-enabled tools to support regulatory assessment and scientific decision-making. These regulatory actions underscore the necessity of ethical stewardship in AI deployment.&nbsp;</p>



<p><strong>Almac Insight&nbsp;–&nbsp;</strong><a href="https://www.linkedin.com/in/mike-hutton-58a99b2/" target="_blank" rel="noreferrer noopener"><strong>Mike Hutton, Director – Strategic Partnerships &amp; Commercialisation:</strong></a><strong></strong>&nbsp;</p>



<p><em>“We are seeing AI move from a future-state ambition to a present-day enabler. The focus now is not whether to use AI, but how to apply it responsibly, in ways that are transparent,&nbsp;validated, and clearly aligned with patient safety and regulatory expectations.&nbsp;Ethical considerations must be at the forefront of every AI initiative, ensuring that technology serves the best interests of patients and the broader clinical community.”</em>&nbsp;</p>



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<h4 class="wp-block-heading" id="h-decentralised-and-hybrid-trials-become-the-norm-nbsp">Decentralised and Hybrid Trials Become the Norm&nbsp;</h4>



<p>Decentralised clinical trial (DCT) models are no longer driven by necessity&nbsp;alone,&nbsp;they are increasingly chosen by design. Hybrid approaches that blend site-based and remote elements are delivering measurable improvements in patient access, engagement, and retention, while easing operational pressure on sites.&nbsp;</p>



<p>Technologies such as electronic consent, remote data capture, and wearable devices are now widely accepted across regulatory&nbsp;jurisdictions. However, decentralisation introduces new complexities, particularly around&nbsp;data integration, operational oversight, and consistency across geographies.&nbsp;</p>



<p><strong>Almac Insight –&nbsp;</strong><a href="https://www.linkedin.com/in/abi-pesun-nee-stanley-13a198121/" target="_blank" rel="noreferrer noopener"><strong>Abi Pesun,&nbsp;Vice President,&nbsp;Operations:</strong></a><strong></strong>&nbsp;</p>



<p><em>“Decentralisation works best when it is intentional rather than reactive. The&nbsp;real challenge,&nbsp;and opportunity,&nbsp;lies in designing hybrid models that respect patient preferences while&nbsp;maintaining&nbsp;operational clarity and data integrity across the entire study.”</em>&nbsp;</p>



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<h4 class="wp-block-heading" id="h-interoperability-and-platform-integration-reduce-technology-burden-nbsp">Interoperability and Platform Integration Reduce Technology Burden&nbsp;</h4>



<p>One of the most persistent challenges in clinical operations&nbsp;remains&nbsp;technology fragmentation. Sponsors and CROs often rely on multiple systems across&nbsp;eCOA, RTSM, EDC, eTMF, and analytics, creating unnecessary complexity and manual reconciliation.&nbsp;</p>



<p>Throughout&nbsp;2026, the industry will increasingly prioritise&nbsp;integrated, interoperable platforms&nbsp;that provide&nbsp;a single source&nbsp;of truth, reduce administrative burden, and enable real-time, cross-functional insights. This shift is not just about IT efficiency,&nbsp;it directly&nbsp;impacts&nbsp;study timelines, data quality, inspection readiness, and team productivity.&nbsp;</p>



<p><strong>Almac Insight –&nbsp;</strong><a href="https://www.linkedin.com/in/cheryl-kole-66520b6/" target="_blank" rel="noreferrer noopener"><strong>Cheryl Kole,&nbsp;Vice President,&nbsp;Strategy&nbsp;and Commercialisation&nbsp;</strong></a>&nbsp;</p>



<p><em>“Interoperability is no longer a ‘nice to have’.&nbsp;Sponsors want solutions that work together by design, not through layers of custom integration. Reducing tech burden&nbsp;ultimately frees&nbsp;teams to focus on science rather than systems.”</em>&nbsp;</p>



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<h4 class="wp-block-heading" id="h-regulatory-alignment-in-a-digital-first-clinical-environment-nbsp">Regulatory Alignment in a Digital-First Clinical Environment&nbsp;</h4>



<p>As technology advances, regulatory frameworks are evolving to ensure innovation is underpinned by robust governance. Both the FDA and EMA are expanding guidance around&nbsp;digital evidence, real-world data, AI-enabled decision support, and quality systems, reinforcing the importance of traceability, validation, and lifecycle oversight.&nbsp;</p>



<p>This&nbsp;year&#8217;s&nbsp;success will depend on selecting technologies that are not only innovative, but&nbsp;designed with regulatory expectations in mind,&nbsp;enabling sponsors to scale digital approaches with confidence rather than caution.&nbsp;</p>



<p><strong>Almac Insight –&nbsp;</strong><a href="https://www.linkedin.com/in/mattlowrie/" target="_blank" rel="noreferrer noopener"><strong>Matthew Lowrie, Director,&nbsp;QA &amp; Regulatory Compliance</strong></a>&nbsp;</p>



<p><em>“Regulatory compliance must not be an afterthought. The most effective clinical technologies are those built with inspection readiness, auditability, and long-term compliance embedded from the outset.”</em>&nbsp;</p>



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<h4 class="wp-block-heading" id="h-practical-innovation-at-the-intersection-of-technology-and-trust-nbsp">Practical Innovation at the Intersection of Technology and Trust&nbsp;</h4>



<p>The most impactful clinical technologies&nbsp;this year&nbsp;will not be defined by novelty, but by&nbsp;usability, integration, and governance readiness. AI will become embedded rather than experimental. Decentralised models will mature into standard practice. Integrated platforms will replace fragmented ecosystems. And regulators will continue to shape how digital evidence is generated and trusted.&nbsp;</p>



<p>For sponsors, CROs, and technology partners alike, the path forward is clear: invest in solutions that reduce complexity, enable smarter decision-making, and place patient outcomes at the centre of innovation.&nbsp;</p>



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<p><strong>Disclaimer:&nbsp;&nbsp;</strong>&nbsp;</p>



<p>The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position or policies of Almac Clinical Technologies or Almac Group (“Almac”).&nbsp;&nbsp;</p>



<p>Almac is committed to the ethical and responsible exploration of new and emerging technologies. We prioritise rigorous internal evaluation, validation, and continuous improvement to ensure that all current and future solutions are trusted, reliable, and regulatory-ready.&nbsp;</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/post-scope-expert-insights-and-predictions-for-the-rest-of-2026/">Post SCOPE: Expert Insights and Predictions for the rest of 2026 </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>What is eCOA in Clinical Trials? A Strategic Enabler for Participant Engagement and Data Integrity</title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/what-is-ecoa-in-clinical-trials-a-strategic-enabler-for-participant-engagement-and-data-integrity/</link>
		
		<dc:creator><![CDATA[chloefinch]]></dc:creator>
		<pubDate>Thu, 14 Aug 2025 08:47:04 +0000</pubDate>
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					<description><![CDATA[<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/what-is-ecoa-in-clinical-trials-a-strategic-enabler-for-participant-engagement-and-data-integrity/">What is eCOA in Clinical Trials? A Strategic Enabler for Participant Engagement and Data Integrity</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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<p style="margin: 0; font-weight: bold;">By Nathan Blubaugh</p>
<p style="margin: 0;">Product Manager at Almac Clinical Technologies</p>
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<p>As clinical trials become more complex and data-driven, electronic Clinical Outcome Assessments (eCOA) have emerged as a vital tool in digital trial transformation. For clinical operations leaders familiar with IRT, eCOA offers a complementary solution—digitising participant-centred data collection to improve engagement and data quality.</p>
<p>By replacing paper-based questionnaires with validated, compliant digital tools, eCOA enables real-time input from participants, clinicians, and caregivers. Whether capturing symptoms, adverse events, or quality-of-life measures, eCOA ensures timely, contextual, and consistent assessments, streamlining oversight and enhancing endpoint interpretation.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>Understanding eCOA’s Role in Clinical Research</strong></h3>
<p>eCOA transforms traditional Clinical Outcome Assessments (COAs)—standardised tools used to measure participant health—into digital formats. These fall into four core categories:</p>
<ul>
<li><strong>ePRO (Patient-Reported Outcomes)</strong> – completed directly by the participant</li>
<li><strong>eClinRO (Clinician-Reported Outcomes)</strong> – completed by trained study personnel</li>
<li><strong>eObsRO (Observer-Reported Outcomes)</strong> – completed by caregivers or study partners</li>
<li><strong>ePerfO (Performance Outcomes)</strong> – based on measurable tasks performed by the participant</li>
</ul>
<p>Beyond operational benefits, eCOA strengthens participant engagement by making participants feel heard and valued. This aligns with ethical, participant-centred research principles and supports higher-quality data. As vendors integrate eCOA with broader digital health ecosystems, real-time insights and improved outcomes become increasingly achievable.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>The Strategic Value of eCOA: Beyond Operational Efficiency</strong></h3>
<p>While IRT systems optimise trial supply and randomisation workflows, eCOA elevates participant engagement and outcome fidelity. Together, they form the operational and evidentiary backbone of modern clinical trials.</p>
<p><strong>Key Benefits for Clinical Operations Teams:</strong></p>
<ul>
<li>Real-time data capture: Enables faster issue detection and earlier interventions.</li>
<li>Protocol adherence: Supports window compliance and reduces protocol deviations.</li>
<li>Data completeness: Reduces missing data by guiding participant inputs through logic checks and reminders.</li>
<li>Scalability: Supports multi-language and decentralised trial formats seamlessly.</li>
<li>Integration-ready: Interoperable with IRT, EDC, and CTMS systems, creating a unified trial infrastructure.</li>
</ul>
<p>In trials where subjective endpoints matter—such as pain, fatigue, mood, or mobility—eCOA ensures those insights are captured consistently and reliably. This directly improves the confidence of data used in statistical analyses and regulatory submissions.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>Why Participant Engagement Matters</strong></h3>
<p>Engaged participants are more likely to adhere to protocols, attend visits, and provide accurate data—boosting retention and ensuring valid results. Their proactive involvement also supports early issue detection and better symptom management, enhancing both trial outcomes and participant satisfaction.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>How eCOA Enhances Engagement</strong></h3>
<p>eCOA systems are designed for accessibility, offering intuitive interfaces, clear instructions, and timely reminders. This ease of use encourages accurate, on-time data entry across diverse participant populations.</p>
<p>Unlike paper-based methods, eCOA allows participants to complete assessments remotely, reducing site visits and fitting participation into daily routines. This flexibility improves compliance and reduces placebo effects by capturing data in natural environments.</p>
<p>Real-time feedback and confirmation further connect participants to the research process, while enabling prompt issue resolution and sustained engagement throughout the study.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>Clarifying the Differences: ePRO, eClinRO, eObsRO, and ePerfO</strong></h3>
<p>Understanding the eCOA landscape requires clarity on its modalities:</p>
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<th style="text-align: left;">Assessment Type</th>
<th style="text-align: left;">Completed By</th>
<th style="text-align: left;">Example</th>
</tr>
</thead>
<tbody>
<tr>
<td>ePRO</td>
<td>The Participant</td>
<td>Participant answers questions about their health.<br />
<strong>PHQ‑9:</strong> “How often have you felt little interest or pleasure in doing things?”</td>
</tr>
<tr>
<td>eClinRO</td>
<td>Study clinician</td>
<td>Clinician interviews a participant to determine the severity of their depression.<br />
<strong>MADRS:</strong> Clinician rates how concentration has been affected on a 0–6 scale.</td>
</tr>
<tr>
<td>eObsRO</td>
<td>Caregiver or study partner</td>
<td>Observer notes abilities, mood, behaviour, or routine disruption in paediatric/geriatric settings.<br />
<strong>VABS‑3:</strong> Child rides a bike without falling? Never, Sometimes, or Usually.</td>
</tr>
<tr>
<td>ePerfO</td>
<td>Participant (task‑based)</td>
<td>Timed walking tests, word recall, reaction time assessments.<br />
<strong>6MWT:</strong> Distance travelled after walking for 6 minutes at their own pace.</td>
</tr>
</tbody>
</table>
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						<p>These instruments may be used independently or in combination depending on therapeutic area, protocol design, and regulatory requirements.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>Integrating eCOA with Broader Trial Systems</strong></h3>
<p>The true power of eCOA emerges when it integrates with existing trial infrastructure. Seamless connectivity with IRT enables coordinated scheduling of assessments and visit windows, while integration with EDC and CTMS ensures downstream data availability and centralised monitoring.</p>
<p>For example:</p>
<ul>
<li>IRT triggers eCOA when a participant is randomised or a visit window opens</li>
<li>eCOA status informs IRT to manage visit progression and supply release</li>
<li>EDC pulls validated eCOA data for statistical analysis and medical review</li>
</ul>
<p>This interoperability reduces manual reconciliation, streamlines operational workflows, and accelerates decision-making.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>The Future of eCOA in Clinical Trials</strong></h3>
<p>eCOA represents a pivotal shift in clinical research—enhancing accuracy, efficiency, and participant experience. Its real-time capabilities reduce manual errors and support data-driven decisions.</p>
<p>Looking ahead, integration with wearables, AI, and interoperable systems will enable more personalised and effective trials. As adoption grows, eCOA will accelerate therapy development and improve participant care, cementing its role in the future of clinical research.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>Conclusion: The Future of Participant-Centric Clinical Trials with eCOA</strong></h3>
<p>Electronic Clinical Outcome Assessments (eCOA) are redefining how clinical trials are conducted—shifting from paper-based methods to digital platforms that prioritise accuracy, efficiency, and participant experience. By enabling real-time, high-quality data collection and fostering stronger participant engagement, eCOA supports more ethical, inclusive, and effective research.</p>
<p>As the technology evolves, integration with wearables, AI, and interoperable health systems will unlock even greater potential—enabling personalised insights and accelerating decision-making. For sponsors, sites, and participants alike, eCOA represents a strategic investment in the future of clinical research.</p>
<p>In short, eCOA is not just a tool—it’s a catalyst for smarter, more participant-focused trials that deliver better outcomes and faster innovation.</p>
<h3 style="margin-top: 32px; margin-bottom: 8px;"><strong>Next Steps for Clinical Teams</strong></h3>
<p>To learn how Almac’s integrated eCOA and IRT solutions can streamline your trial operations and improve participant data quality, visit: <a href="https://www.almacgroup.com/clinical-technologies" target="_blank" rel="noreferrer noopener">https://www.almacgroup.com/clinical-technologies</a></p>
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<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/what-is-ecoa-in-clinical-trials-a-strategic-enabler-for-participant-engagement-and-data-integrity/">What is eCOA in Clinical Trials? A Strategic Enabler for Participant Engagement and Data Integrity</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Improving Site Efficiency with Automated Drug Resupply and Forecasting </title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/improving-site-efficiency-with-automated-drug-resupply-and-forecasting/</link>
		
		<dc:creator><![CDATA[chloefinch]]></dc:creator>
		<pubDate>Wed, 09 Jul 2025 08:19:17 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=4263</guid>

					<description><![CDATA[<p>Clinical trials are complex undertakings, but the greatest operational burden often falls on the clinical sites. These sites are responsible for managing the critical components that drive trial success. Recognising these components as the building blocks of a successful clinical trial is essential. Sites are tasked with recruitment and retention, data collection, data integrity, regulatory [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/improving-site-efficiency-with-automated-drug-resupply-and-forecasting/">Improving Site Efficiency with Automated Drug Resupply and Forecasting </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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																<h3>By Casey Doyle</h3>
<h3>Clinical Project Services | Group Leader | Almac Clinical Technologies</h3>
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<p>Clinical trials are complex undertakings, but the greatest operational burden often falls on the clinical sites. These sites are responsible for managing the critical components that drive trial success. Recognising these components as the building blocks of a successful clinical trial is essential. Sites are tasked with recruitment and retention, data collection, data integrity, regulatory compliance, protocol knowledge and expertise, meeting sponsor expectations, administrative tasks, ensuring appropriate facilities for diverse participant needs, cost management, and prioritising the safety, well-being, and ethics of participants.&nbsp;</p>



<p>To navigate the complexities surrounding these tasks, it is crucial to ensure that sites are set up for success by implementing technological resources that allow them to structure their workflow, enhance data accuracy, improve protocol adherence, and proactively address operational challenges.&nbsp;</p>



<p>With the availability of appropriate technology, such as an IRT system or an eClinical technology solution, clinical sites can focus more on the most important part of a clinical trial – the participants. Interactive Response Technology (IRT) and eClinical providers help streamline processes and workflows to reduce errors, administrative burdens, and potential interruptions in dosing, thereby allowing for greater patient engagement. In this article, we will specifically focus on how an IRT system can improve site operational efficiency through automated drug resupply and forecasting.&nbsp;</p>



<p><strong>How does IRT replace manual inventory tracking?</strong></p>



<p>During the design phase of an Interactive Response Technology (IRT) system, the sponsor shares the clinical trial protocol with the IRT provider. This protocol includes participant visit schedules and dosing plans. The IRT system then programs these visits, making it easy for users to track participant progress in real-time as visits are recorded.&nbsp;</p>



<p>The IRT system uses coded logic to provide the right treatment at the right time, based on the visit schedule and dosing plans. This real-time registration helps with accurate tracking of medication assignments.&nbsp;</p>



<p>The IRT system also uses predictive algorithms to figure out when more supplies are needed. It looks at several data points, such as:&nbsp;</p>



<ul class="wp-block-list">
<li><strong>Current site inventory</strong>: How much supply is available at the site right now?&nbsp;</li>
</ul>



<ul class="wp-block-list">
<li><strong>Supply expiry</strong>: When will the supplies expire? The system stops counting supplies as available inventory before they expire to avoid using expired drugs.&nbsp;</li>
</ul>



<ul class="wp-block-list">
<li><strong>Site resupply strategy:</strong> The system can be set with trigger values depending on whether a site is enrolling many or few participants.&nbsp;</li>
</ul>



<p>The IRT system can also look ahead to determine if there will be enough supplies for future visits. If not, it will automatically place orders to ensure there is enough inventory.&nbsp;</p>



<p>With IRT or eClinical technology solutions, these considerations are handled automatically using real-time data. There is no need for manual coordination or paper trails, making the process effortless and accurate.&nbsp;</p>



<p><strong>How do IRT inputs drive predictive resupply data?</strong></p>



<p>Interactive Response Technology (IRT) or broader eClinical solutions enable real-time visibility into critical data inputs such as registered participant visits, kit replacements due to loss or damage, and inventory adjustments. These inputs directly influence the clinical supply status at each site.</p>



<p>With this real-time data, stakeholders including clinical site staff, monitors, Sponsors, and CROs can track inventory fluctuations and monitor supply shipments from depot to site. This visibility is typically delivered through IRT dashboards, which display current site inventory alongside in-transit and unacknowledged shipments.</p>



<p>Dynamic reporting further enhances this visibility by enabling users to review and forecast site needs. These reports are available in both blinded and unblinded formats, tailored to user access levels, and support a wide range of operational decisions. Key reporting features include:</p>



<ul class="wp-block-list">
<li><strong>Inventory Summary:</strong> A breakdown of supplies in various statuses – i.e. Available, In Transit, Quarantined, Damaged, Missing, Expiring, Expired, On-hold for Relabeling, Accounted, Reconciled, Returned, Destroyed (at site).</li>



<li><strong>Numbered and non-numbered supply: </strong>Status tracking for individual kits.</li>



<li><strong>Site Shipments:</strong> Overview of site shipments and statuses along with information such as date ordered, date expected, and date acknowledged.</li>



<li><strong>Supply Projections:</strong> Generation of supply needs for the current date based off predictive algorithm plus inclusion of visit or rand projections.</li>
</ul>



<p>Monitoring inventory changes closely reduces the risk of stockouts and enables proactive decisions to minimise overages. &nbsp;This is especially important in trials with expensive or temperature sensitive drugs.</p>



<p><strong>How does IRT ensure protocol adherence through system-driven logic?</strong></p>



<p>To ensure the credibility of clinical trial research, Sponsors rely on clinical sites to adhere strictly to protocol. Interactive Response Technology (IRT) or broader eClinical solutions play a critical role in supporting compliance. These systems not only safeguard data integrity but also uphold quality by embedding protocol-specific rules directly into their validated configurations. This system-driven logic ensures consistent execution across sites, reducing variability and minimising the risk of protocol deviations</p>



<div class="wp-block-media-text is-stacked-on-mobile" style="grid-template-columns:15% auto"><figure class="wp-block-media-text__media"><img fetchpriority="high" decoding="async" width="589" height="690" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Kit-rules_2.jpg" alt="" class="wp-image-4279 size-full" srcset="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Kit-rules_2.jpg 589w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Kit-rules_2-256x300.jpg 256w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Kit-rules_2-478x560.jpg 478w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Kit-rules_2-273x320.jpg 273w" sizes="(max-width: 589px) 100vw, 589px" /></figure><div class="wp-block-media-text__content">
<p><strong>1. Kit-Type Rules</strong></p>



<p>Ensure only protocol-approved kits are shipped and dispensed.</p>
</div></div>



<div class="wp-block-media-text is-stacked-on-mobile" style="grid-template-columns:15% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="589" height="690" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Binding.jpg" alt="" class="wp-image-4276 size-full" srcset="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Binding.jpg 589w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Binding-256x300.jpg 256w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Binding-478x560.jpg 478w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Binding-273x320.jpg 273w" sizes="(max-width: 589px) 100vw, 589px" /></figure><div class="wp-block-media-text__content">
<p><strong>2. Blinding &amp; Randomisation</strong></p>



<p>Prevent bias and maintain treatment balance while minimising stockout risk.</p>
</div></div>



<div class="wp-block-media-text is-stacked-on-mobile" style="grid-template-columns:15% auto"><figure class="wp-block-media-text__media"><img decoding="async" width="589" height="690" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Controlled-dispensing.png" alt="" class="wp-image-4277 size-full" srcset="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Controlled-dispensing.png 589w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Controlled-dispensing-256x300.png 256w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Controlled-dispensing-478x560.png 478w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/07/Controlled-dispensing-273x320.png 273w" sizes="(max-width: 589px) 100vw, 589px" /></figure><div class="wp-block-media-text__content">
<p><strong>3. Controlled Dispensing</strong></p>



<p>Dispense only when needed per protocol visit, optimising inventory and reducing waste from overages or expiry.</p>
</div></div>



<p>Compared to paper-based tracking, IRT systems apply rules such as kit limits per subject per visit, resupply strategies, and expiry tracking. These mechanisms help to monitor and maintain inventory thresholds effectively. By setting these limits, IRT ensures that sites receive only the necessary amount of drug, which proactively prevents expiry events from interrupting participant dosing.</p>



<p>Additionally, IRT and eClinical platforms enhance regulatory compliance by generating detailed electronic records and audit trails. &nbsp;This not only strengthens data integrity but also simplifies site inspections and inventory reconciliation at study closeout, minimising the burden of maintaining paper documentation.</p>



<p><strong>How does IRT empower sites to manage inventory proactively?</strong><strong></strong></p>



<p>When an IRT or eClinical technology is <em>not</em> used, sites must manually forecast and manage inventory for both current and future participants. This creates an endless cycle of manual demand planning which is both error-prone, labor-intensive, and assumes the risk of potentially under or over-stocking. If a site is understocked, participant treatments will be interrupted which can have negative implications for end-point evaluations but even more so for participants’ safety. If a site is overstocked, there is a risk of wastage which can have significant financial impact to the overall trial in addition to added up front cost to the sites coordinating excess return shipments with couriers. Utilising an IRT or eClinical technology for sites alleviates these pain points.</p>



<p>IRT or eClinical technology alleviates these burdens by enabling real-time visit tracking and automatic inventory updates. Sites can log visits and flag missing, damaged, or quarantined kits, which are instantly removed from available stock. A built-in predictive algorithm then replenishes the stock to meet the site&#8217;s needs, eliminating the need for manual calculations and orders for replacement supplies. As the site&#8217;s needs change, the resupply strategy can adapt accordingly, such as with varying enrollment activities or the elimination of certain kit types as participants progress through treatment phases. In the IRT, the kit type that is no longer required can be removed from the resupply strategy, preventing the management of unnecessary returns or on-site kit destruction.</p>



<p><strong>How does IRT allow sites to better manage protocol evolution?</strong></p>



<p>Over the course of a clinical trial, there are always possibilities for amendments for extensions, study design, procedures, etc. to provide further evidence and tracking of functional outcomes against the hypothesis. The Inclusion of an IRT or eClinical solution provides seamless supply coverage for sites without interruption as products are automatically replenished using the predictive algorithm. &nbsp;When visit schedules, treatment arms, or enrollment thresholds are updated, the IRT system reflects these changes in real time. This enables sites to continue operations without disruption. Sites can maintain continuity in participant dosing, avoid manual recalculations, and ensure compliance with the latest protocol changes.</p>



<p><strong>Final Thoughts:</strong></p>



<p>Clinical sites are the backbone of trial success, yet they face significant operational pressures. Implementing an IRT or eClinical solution shifts the burden of manual inventory tracking, forecasting, and protocol compliance to an automated, real-time system, freeing site staff to focus on participant care.</p>



<p>With predictive resupply, real-time dashboards, and built-in protocol logic, IRT ensures sites maintain optimal inventory levels, avoid dosing interruptions, and minimise waste. It adapts to protocol changes and enrollment trends without disrupting workflow. Most importantly, it empowers sites to operate efficiently, compliantly and confidently, supporting both trial integrity and participant safety.</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/improving-site-efficiency-with-automated-drug-resupply-and-forecasting/">Improving Site Efficiency with Automated Drug Resupply and Forecasting </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Future Predictions for Clinical Technologies: A Smarter, More Connected Era</title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/future-predictions-for-clinical-technologies-a-smarter-more-connected-era/</link>
		
		<dc:creator><![CDATA[thomasdrake]]></dc:creator>
		<pubDate>Mon, 16 Jun 2025 14:14:03 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=4236</guid>

					<description><![CDATA[<p>2025 marks the beginning of a new phase in clinical trial execution—one where sponsors will no longer tolerate disjointed systems or settle for fragmented insights. Instead, we will see an accelerated move toward interconnected portfolios of solutions, blending best-in-class technology with intelligent services. But this is just the start.&#160; Looking ahead, here’s how I believe [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/future-predictions-for-clinical-technologies-a-smarter-more-connected-era/">Future Predictions for Clinical Technologies: A Smarter, More Connected Era</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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																<h3>By Kees Van Ooik</h3>
<h3>Vice President of Client Solutions | Almac Clinical Technologies</h3>
<p>&#8220;In 2025, I predict a transformative shift in clinical trials, where sponsors will embrace interconnected portfolios of solutions that go beyond just software.&#8221;</p>
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<p>2025 marks the beginning of a new phase in clinical trial execution—one where sponsors will no longer tolerate disjointed systems or settle for fragmented insights. Instead, we will see an accelerated move toward interconnected portfolios of solutions, blending best-in-class technology with intelligent services. But this is just the start.&nbsp;</p>



<p>Looking ahead, here’s how I believe this shift will evolve and shape the clinical technology landscape through 2025 and beyond.&nbsp;</p>



<p><strong>The Rise of Modular Ecosystems&nbsp;</strong></p>



<p>Sponsors are already starting to reject rigid, monolithic software platforms that require full system adoption for partial value. In their place, modular ecosystems will rise—configurable, interoperable, and tailored to the unique needs of each study or program and equally as important, around the participant’s clinical trial journey. These systems will plug-and-play through standardised APIs and data structures, allowing sponsors to select the right tools for the right job.&nbsp;</p>



<p>Crucially, this isn’t just about software—it’s about creating intelligent workflows across services and systems. Expect to see smoother cross-function integrations between IRT, eCOA, CTMS, eConsent, and even lab and supply chain solutions.&nbsp;</p>



<p>The result? Sponsors will gain greater control, faster study start-up, and increased customisation—without sacrificing data cohesion or speed—while also reducing quality risks.&nbsp;</p>



<p><strong>Predictive and Prescriptive Intelligence Will Drive Decision-Making&nbsp;</strong></p>



<p>We’ve spent the past decade digitising clinical operations—but the next frontier is intelligent automation. 2025 will bring a new era where systems do more than track and alert—they predict, recommend, and act. While these capabilities are still emerging, the industry is moving toward embedding intelligence directly into operational tools:&nbsp;</p>



<ul class="wp-block-list">
<li>Predictive analytics will forecast patient recruitment bottlenecks, drug resupply needs, and protocol deviations before they happen.</li>



<li>Prescriptive&nbsp;analytics&nbsp;will suggest optimised site visit schedules, dosing windows, and even adaptation triggers based on real-time trial data.</li>



<li>And most importantly, this intelligence will be embedded into operational tools, not just analytics dashboards.</li>
</ul>



<p>This will dramatically reduce the administrative burden on sites and study teams, freeing up time and brainpower to focus on what matters most—patient care and scientific insight.&nbsp;</p>



<p><strong>Digital Trust and Governance Will Become Strategic Priorities&nbsp;</strong></p>



<p>With more systems connected and more data flowing between them, data governance and trust will move from the compliance office into the C-suite. Sponsors will no longer view regulatory readiness as a checkbox—it will be a strategic differentiator.&nbsp;</p>



<p>Expect to see:&nbsp;</p>



<ul class="wp-block-list">
<li>More robust audit trails and identity management across platforms.</li>



<li>Advanced data lineage tracing—answering not just “what happened?” but “where did this data originate, and who touched it?”</li>



<li>Growing adoption of zero-trust architectures, where no system or user is inherently trusted without continuous verification.</li>
</ul>



<p>These governance strategies will not only meet rising global privacy standards but also ensure data integrity in complex, decentralised, and hybrid trial designs.&nbsp;</p>



<p><strong>The Human Experience Will Be Designed, Not Assumed</strong></p>



<p>Technology will only be as effective as it is intuitive and human-centric. A growing realisation in our industry is that every touchpoint—from a site entering data in the IRT to a patient completing a daily diary—is a moment that matters.&nbsp;</p>



<p>That’s why the next wave of solutions will be designed with the end user in mind, supported by:&nbsp;</p>



<ul class="wp-block-list">
<li>Embedded coaching and real-time support for sites and patients.</li>



<li>Intuitive interfaces that reduce cognitive load.</li>



<li>Seamless language localisation and accessibility features by default.</li>
</ul>



<p>Design thinking, user testing, and behavioural science will become embedded in how we develop and implement clinical technologies—not as an afterthought, but as a core requirement.&nbsp;</p>



<p><strong>The Industry Will Co-Create the Future&nbsp;</strong></p>



<p>Perhaps the most exciting prediction is this: the future won’t be built by vendors alone. It will be co-created by sponsors, CROs, technology providers, and participant advocacy groups working together in agile, feedback-driven partnerships.&nbsp;</p>



<p>In fact, some of the most impactful innovations of 2025 will come not from a software upgrade, but from collaborative innovation labs, shared playbooks, and open-source data models. The barriers between “provider” and “client” will blur, replaced by a shared commitment to operational excellence and patient outcomes.&nbsp;</p>



<p><strong>Final Thoughts: A Connected Future Is a Capable Future&nbsp;</strong></p>



<p>The clinical technologies of the near future will not be defined by features, but by their ability to adapt, integrate, and empower. As sponsors embrace interconnected portfolios of solutions, we’ll see the emergence of a new operating model for trials—one where speed, quality, and insight are no longer at odds.&nbsp;</p>



<p>At Almac, we’re excited to help lead this evolution—bridging the best of technology with deep clinical expertise to create solutions that work for every stakeholder in the ecosystem. That’s one of the key reasons I, as founder of Your Research, made the decision to join the Almac Group.&nbsp;</p>



<p>Because ultimately, the goal is not just to run better trials. It’s to bring better treatments to patients, faster—and the future we’re building is designed to do exactly that.&nbsp;</p>



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<p><strong>Join Kees Live:</strong><br>Kees will be speaking at the upcoming <strong>Clinical Leader Solutions Expo – Smart Sourcing: EDC, eCOA, &amp; Data Management Online Showcase</strong> on <strong>27th August</strong>. Don’t miss the opportunity to see a <strong>live demo of our eCOA platform</strong>.<strong> </strong></p>



<p>Register here: <a href="https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fevent.on24.com%2Fwcc%2Fr%2F5007345%2F467961ECFD81169DC3E963D3A75E7A98%3Fpartnerref%3Dcalendarinvite&amp;data=05%7C02%7Cchloe.finch%40almacgroup.com%7C8960693112534197f96c08ddd68cb731%7Cf3c459be14e14ac69006b6c68b68ef64%7C0%7C0%7C638902623687268492%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=KoFhXkyTrVHXDErs2ovqn6P4UrpP%2Bxad3gwkLMKkGbg%3D&amp;reserved=0">Smart Sourcing: EDC, eCOA, &amp; Data Management Showcase</a></p>



<p><strong>____________________________________________________________________________________</strong>&nbsp;</p>



<p><strong>Disclaimer:&nbsp;&nbsp;</strong></p>



<p>The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position or policies of Almac Clinical Technologies or Almac Group (“Almac”).&nbsp;</p>



<p>Almac is committed to the ethical and responsible exploration of new and emerging technologies. We prioritise rigorous internal evaluation, validation, and continuous improvement to ensure that all current and future solutions are trusted, reliable, and regulatory-ready.&nbsp;</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/future-predictions-for-clinical-technologies-a-smarter-more-connected-era/">Future Predictions for Clinical Technologies: A Smarter, More Connected Era</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Seamless Support: how Almac&#8217;s helpdesk elevates clinical trials </title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/seamless-support-how-almacs-helpdesk-elevates-clinical-trials/</link>
		
		<dc:creator><![CDATA[chloefinch]]></dc:creator>
		<pubDate>Thu, 29 May 2025 11:07:51 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[IRT Clinical Trials]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=4217</guid>

					<description><![CDATA[<p>Daniel Magill Director of Clinical Project Services &#124; Almac Clinical Technologies We are living in an age of unprecedented technological progress; from AI to self-driving vehicles and the omnipresent personal phone, we are exposed daily to an increasingly diverse range of technological wonders. Within clinical trials, Interactive Response Technology (IRT) is at the forefront as the [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/seamless-support-how-almacs-helpdesk-elevates-clinical-trials/">Seamless Support: how Almac&#8217;s helpdesk elevates clinical trials </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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<p><strong>Daniel Magill </strong></p>



<p><em>Director of Clinical Project Services </em>| <em>Almac Clinical Technologies </em></p>



<p>We are living in an age of unprecedented technological progress; from AI to self-driving vehicles and the omnipresent personal phone, we are exposed daily to an increasingly diverse range of technological wonders. Within clinical trials, Interactive Response Technology (IRT) is at the forefront as the complexities of protocol design increase. IRT providers are offering innovative approaches for novel study designs, with a keen eye towards delivering a streamlined user experience, making it easier for all involved in a clinical trial. At Almac Clinical Technologies we are pioneers in providing IRT solutions and ensuring our staff have the requisite skills to support our users.&nbsp;</p>



<p>When questions or issues arise, as they invariably will, it is critical that the support service matches the technological offering. The first point of contact for sites and sponsors regarding questions about the randomization and trial supply technology will often be the IRT providers Helpdesk. Almac Clinical Technologies’ Helpdesk staff take personal pride in providing best in class customer experience.&nbsp;</p>



<p><strong>Balancing Technology and Human Connection&nbsp;</strong></p>



<p>While technology enhances connectivity between the site, sponsor, and the Helpdesk, it may inadvertently create a gap between the Helpdesk support staff and the patient waiting at the site for their treatment. At Almac, we work to bridge this gap.&nbsp;</p>



<p>Often described as a passionate visionary and philanthropist, Sir Allen McClay—Founder and Chairman of Almac Group—always believed that people were our greatest asset. At Almac, we recognise the value of our staff and ensure we provide them with not just the technology tools to support clinical trials, but also the training and understanding to complement and enhance the technological offerings. The goal being to reduce the time patients and sites are impacted, while being conscious of the unique user journey each patient and user has. Part of our training involves a peer led review of a subset of our support cases each month. This review helps empower our team to critically evaluate their own performance, highlighting both exemplary service and areas for improvement.&nbsp;&nbsp;</p>



<p><strong>The Almac TIER-ed Approach to Support&nbsp;</strong></p>



<p>At Almac, we developed a TIER-ed approach to support. Not only in the levels of support we provide, but also, how we deliver that support.&nbsp;</p>



<p><strong>T – Time</strong>&nbsp;</p>



<p>Patients could have travelled for hours, for many miles to reach the clinical site. Clinical staff could be running multiple studies across multiple sponsors every day. Time is precious for everyone, whether they are a patient in the trial, an investigator running the trial or a sponsor managing the trial. With our IRT, we have an intuitive system that helps the end user not only navigate the system but also provides an enhanced self-help offering.&nbsp; In addition, having omnichannel contact options, along with appropriately skilled staff to address the issue, means that no matter what the question is, you can be assured that it will be dealt with as effectively and efficiently as possible.&nbsp;</p>



<p><strong>I – Integrity&nbsp;</strong>&nbsp;</p>



<p>The simple act of just listening is a very powerful and sometimes underutilised skill. While time to resolve is a key factor, taking time to listen and ask relevant questions is equally important.&nbsp; The ability to listen, not interrupt and summarise what you have heard is vital when it comes to providing exceptional customer service. By actively listening, one can often determine the root cause of an issue, not just the symptom of it, that the end user may be experiencing. Combine this with transparency &#8211; being honest about what the issue is and expected resolution time &#8211; significantly helps build trust and lets the end user feel confident that we can provide resolution.&nbsp;</p>



<p><strong>E – Empathy</strong>&nbsp;</p>



<p>We work hard to ensure our staff understand how the service they provide can have a significant impact on patients and site staff. We ensure that the same level of care and attention is given to all queries no matter how small or large; from routine account unlocks or password resets to a critical situation where a patient is on site awaiting drug assignment. Our training programmes emphasise the unique patient&#8217;s journey and how every aspect of our support can influence that journey, regardless of how standard a request may seem. By putting ourselves into the shoes of a patient, a parent or a site clinician; we are able to develop a whole new perspective on our role in providing helpdesk support. Understanding the impact of what we do and how we do it, is a key factor in Almac being able to provide consistently high levels of customer service.&nbsp;&nbsp;</p>



<p>&nbsp;<strong>R – Resolution</strong>&nbsp;</p>



<p>When resolving a query, we always ensure it is addressed to the customers complete satisfaction. Looking beyond the surface level and asking relevant questions to establish the full picture is critical as often what the user is experiencing is a symptom of what the actual root cause is.&nbsp; We empower our staff to go that extra mile to identify not just the immediate fix but to proactively assess the situation and prevent any future issues from occurring. Efficiency in resolution should not be at the expense of effectiveness and is key to providing great customer service.&nbsp;</p>



<p><strong>24/7 Global Support&nbsp;</strong></p>



<p>The Almac Clinical Technologies Helpdesk provides 24/7, year-round global support. This support is unified through our omnichannel Customer Relationship Management (CRM) system. Whether your case is picked up in Tokyo, Singapore, Northern Ireland or the US, it will be treated with the same degree of expertise and empathy in each of our locations. In addition to local language support and study specific training, the CRM system provides support staff with bespoke Knowledge Based Articles (KBA) that synchronise project specific information to ensure each support case is effectively triaged, processed and resolved.&nbsp;&nbsp;&nbsp;&nbsp;</p>



<p><strong>Integrating Technology with Human Touch for Exceptional Service&nbsp;</strong></p>



<p>In an era where technological advancements are reshaping industries, the human element remains irreplaceable. Our commitment to providing exceptional customer service through a tiered approach—focusing on Time, Integrity, Empathy, and Resolution—ensures that we not only meet but exceed the expectations of our clients. By integrating cutting-edge IRT solutions with a deeply empathetic and well-trained support team, we bridge the gap between technology and human connection.&nbsp;</p>



<p>Our dedication to continuous improvement, through regular training and peer reviews, empowers our staff to deliver unparalleled support. This holistic approach guarantees that every interaction is handled with the utmost care, precision, and efficiency, ultimately enhancing the overall experience for patients, clinical staff, and sponsors alike.&nbsp;</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/seamless-support-how-almacs-helpdesk-elevates-clinical-trials/">Seamless Support: how Almac&#8217;s helpdesk elevates clinical trials </a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Clinical Technologies: Expert Insights and Predictions for 2025</title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/clinical-technologies-expert-insights-and-predictions-for-2025/</link>
		
		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Tue, 15 Apr 2025 10:09:44 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=4156</guid>

					<description><![CDATA[<p>As the clinical research industry continues its digital transformation, Clinical Technology (ClinTech) software is at the forefront of innovation, shaping how trials are designed, managed, and executed. With emerging technologies like generative AI and hybrid decentralised trial models (DCT) becoming more prominent, the landscape of digital solutions in 2025 is poised for significant evolution. We [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/clinical-technologies-expert-insights-and-predictions-for-2025/">Clinical Technologies: Expert Insights and Predictions for 2025</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p>As the clinical research industry continues its digital transformation, Clinical Technology (ClinTech) software is at the forefront of innovation, shaping how trials are designed, managed, and executed. With emerging technologies like generative AI and hybrid decentralised trial models (DCT) becoming more prominent, the landscape of digital solutions in 2025 is poised for significant evolution.</p>



<figure class="wp-block-image size-large"><img decoding="async" width="1024" height="1024" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-1024x1024.jpg" alt="" class="wp-image-4158" srcset="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-1024x1024.jpg 1024w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-300x300.jpg 300w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-150x150.jpg 150w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-768x768.jpg 768w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-560x560.jpg 560w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-320x320.jpg 320w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-400x400.jpg 400w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all-600x600.jpg 600w, https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/2025_01_YR_carousel-all.jpg 1080w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



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<p>We reached out to key opinion leaders in the industry to share their predictions for 2025. Their insights, coupled with current trends and data, help us theorise where we are headed.</p>



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<h4 class="wp-block-heading" id="h-current-landscape-in-clintech"><strong>Current Landscape in ClinTech</strong></h4>



<p>Over the past few years, ClinTech solutions have rapidly evolved, driven by the need for:</p>



<p><img decoding="async" width="25" height="25" src="https://www.almacgroup.com/knowledge/wp-content/uploads/sites/10/2025/03/clock1.png" alt=""><strong>Increased efficiency:</strong> Reducing burdensome manual data processing.</p>



<p><img decoding="async" width="25" height="25" src="https://www.almacgroup.com/knowledge/wp-content/uploads/sites/10/2025/03/heart1.png" alt=""><strong>Improved patient-centricity:</strong> Enhancing accessibility to studies through decentralised trials and digital tools.</p>



<p><img decoding="async" width="25" height="25" src="https://www.almacgroup.com/knowledge/wp-content/uploads/sites/10/2025/03/folder1.png" alt=""><strong>Enhanced data management:</strong> Leveraging AI and real-time data analytics for actionable insights.</p>



<p><img decoding="async" width="25" height="25" src="https://www.almacgroup.com/knowledge/wp-content/uploads/sites/10/2025/03/cloud1.png" alt=""><strong>Increased integration:</strong> Connected platform solutions able to share data on a near-real-time basis for greater performance and operational transparency.</p>



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<h4 class="wp-block-heading" id="h-the-clintech-solutions-market-exemplifies-this-evolution-with-substantial-growth-projections"><strong>The ClinTech solutions market exemplifies this evolution, with substantial growth projections:</strong></h4>



<p><strong>The eClinical global market</strong> is expected to grow from USD 11.6 billion in 2024 to USD 22.1 billion by 2029, reflecting a compound annual growth rate (CAGR) of 13.7% (MarketsandMarkets, 2024)¹.</p>



<figure class="wp-block-image size-full"><img decoding="async" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/eClinical-solutions-market-growth.svg" alt="" class="wp-image-4159"/></figure>



<p>A study by GlobalData reported that approximately 1,300 drug clinical trials with virtual and/or <strong>decentralised components</strong> were expected to commence in 2022. This represents a 28% increase from 2021, which had 1,011 such trials, and a 93% increase from 2020, which had 673 trials (Parkins, K., &amp; Hillman, A., 2021, December 14)².</p>



<figure class="wp-block-image size-full"><img decoding="async" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/Increased-in-decentralised-clincal-trial.svg" alt="" class="wp-image-4160"/></figure>



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<p><strong>Adoption of Digital Tools:</strong> The use of digital data collection methods in DCTs saw a 54% increase in 2021 compared to 2020. Although there was a 16% decrease in 2022 relative to 2021, projections indicate a 13% recovery in 2023, suggesting a continued upward trajectory in the integration of digital technologies within clinical trials – (Fultinavičiūtė, U., &amp; Maragkou, I.,2023, February 6)³.</p>



<figure class="wp-block-image size-full"><img decoding="async" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/Adoption-of-digital-tools-in-DCT.svg" alt="" class="wp-image-4161"/></figure>



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<p><strong>AI adoption</strong>&nbsp;in Clinical Trials is surging, with 81% of organisations utilising AI in at least one drug development area (Norstella), and the AI-driven clinical trials market projected to expand from USD 2.04 billion in 2024 to USD 20.16 billion by 2033, at a CAGR of 28% (Chmielewska, I., &amp; Caruso, S., 2024, October 31)⁴.</p>



<p><strong>Decentralised and hybrid clinical trials</strong>&nbsp;are growing rapidly, with the market valued at USD 9.23 billion in 2024 and anticipated to grow at a CAGR of 7.6% through 2034 (Visiongain Reports Ltd., 2024, June 6)⁵.</p>



<figure class="wp-block-image size-full"><img decoding="async" src="https://www.almacgroup.com/clinical-technologies/wp-content/uploads/sites/8/2025/04/DCT2_updated.svg" alt="" class="wp-image-4162"/></figure>



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<p>This trajectory underscores the industry’s commitment to embedding innovative technologies as core solutions.</p>



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<h4 class="wp-block-heading" id="h-predictions-from-industry-experts"><strong>Predictions from Industry Experts</strong></h4>



<p>Here are the predictions from top thought leaders who see 2025 as a pivotal year for ClinTech solutions:</p>



<p><strong>Doug Bain</strong> Chief Technology Officer, KCR:</p>



<p><strong>Platform / Integrations and AI for 2025</strong></p>



<p>Clinical data platforms (EDC, eCOA, Lab, Digital Instruments) will increasingly support hybrid DCTs alongside clinical operations platforms (CTMS, eTMF, Regulatory) with single sign-on and interoperability. CDISC USDM and ICH M11 standards will enhance consistency from protocol to data integration and delivery.</p>



<p>AI solutions will evolve, starting with generative AI improving existing systems and data, followed by purpose-built AI solutions transforming study implementation, data cleaning, statistical analysis, and submissions. These innovations will streamline processes, reduce manual interventions, and make AI-driven risk-based quality management the gold standard for clinical trial execution.</p>



<p><strong>Joe Dustin</strong> eClinical Tech Executive; Strategy Leader &amp; Advisor in AI, Clinical Operations &amp; Decentralized Trials:</p>



<p><strong>2025: The Rise of Agentic AI in Clinical Research</strong></p>



<p>Agentic AI is set to transform clinical trials by automating complex workflows and streamlining operations. These agents will initially focus on site-level tasks like faster, more accurate EHR reviews and handling live participant pre-screening calls in multiple languages and accents. They’ll also improve data flow efficiency, starting with EHR-to-EDC connections and evolving into direct site-to-sponsor data integration. By reducing workloads, enhancing accuracy, and accelerating timelines, Agentic AI will become an invaluable partner to clinical research teams.</p>



<p><strong>Vivienne van de Walle</strong> Leading Expert and passionate Clinical Research Physician, Keynote Speaker and Thought Leader:</p>



<p><strong>2025: Simplifying the Complexity of Clinical Trials</strong></p>



<p>In 2025, the most impactful eClinical solutions will be those that bring simplicity to the complexity of clinical trial systems. The industry will shift towards purpose-built innovations that prioritise the real-world needs of research sites and participants, ensuring seamless integration and ease of use.</p>



<p><strong>Maya Zlatanova</strong> CEO of TrialHub:</p>



<p><strong>One Step Closer to Predictive Insights.</strong></p>



<p>I’ve seen how AI and real-world data are transforming clinical trials, in effort to make trials smarter and more connected to real lives. In 2025, I believe we’ll go even further in predictive analytics—transforming qualitative data (Standard of Care, electronic health record, social determinants of health etc.) into actionable insights. This is how we’ll create trials that are not only successful but truly patient-friendly.</p>



<p><strong>Dr. Daniel Fox</strong>, MPH, PhD Entrepreneur, Founder, Board Member, Subject Matter Expert, and Thought Leader @ Dr. Fox Ventures:</p>



<p><strong>Increased Demand for Healthcare Integration and Streamlined Systems.</strong></p>



<p>With the official 2024 DCT guidance on the books and a draft randomized clinical trials in healthcare on the way, there will be an increased prevalence of healthcare integration and healthcare stakeholders driving how the research industry creates its eSolutions for streamlined experiences and increased patient access.</p>



<p><strong>Angie Schwab</strong>, MS, PMP Founder &amp; CEO of EZ Research Solutions, Inc</p>



<p><strong>Solutions: AI-Enabled Regulatory Medical Writing &amp; Protocol Digitization:</strong></p>



<p>2025 marks a pivotal year for the accelerated adoption of USDM (Unified Study Data Model) standards, enabling seamless digital data flow across systems and paving the way for innovative, AI-based technologies to thrive. The dramatic rise in connected solutions will eliminate manual processes, significantly shorten timelines, and enhance consistency and compliance across clinical research.</p>



<p><strong>Ross Jackson</strong> (Literally) The Man who Wrote the Book(s) on Patient Recruitment:</p>



<p><strong>AI-Powered Handholding Throughout the Trial Participation Process</strong></p>



<p>A more widespread adoption of existing AI-powered bot-style tools (with both text and voice outputs) to help participants throughout the trial process. These tools will interact with potential participants in an engaging and encouraging manner to aid recruitment, as well as being the first point of contact for any queries enrolled patients may have – thus helping retain them in the trial.</p>



<p><strong>Mike Hutton Ph.D.</strong> Director – Strategic Partnerships and Commercialisation, Almac Clinical Technologies:</p>



<p><strong>AI will make Significant Contributions to Trial Efficiencies</strong></p>



<p>We will start to see AI making significant contributions to trial efficiencies, releasing the human element from the tedium, particularly in data management, to focus on the critical strategic and creative decisions; and this will truly drive the innovation in the industry.</p>



<p><strong>Kees Van Ooik</strong> Vice President eClinical Almac Clinical Technologies and Founder of Your Research:</p>



<p><strong>(Study) Sponsors will embrace Interconnected Portfolios of Solutions</strong></p>



<p>In 2025, I predict a transformative shift in clinical trials, where sponsors will embrace interconnected portfolios of solutions that go beyond just software. The focus will be on combining exceptional services with seamless integration, enabling unparalleled visibility, insight, and efficiency. This evolution will optimise process automation and navigation, breaking free from outdated stand-alone systems and vendor lock-ins, and paving the way for a smarter, more connected future in clinical research.</p>



<p><strong>Duncan McDonald</strong> Consulting Marketing Manager, Almac Clinical Technologies:</p>



<p><strong>Early AI integration to Unified eClinical Workflows</strong></p>



<p>Early adoption of AI will focus on trialling regulatory-compliant solutions, allowing organisations to evaluate whether the benefits justify the effort of implementation. Meanwhile, mid-stage adopters will embrace proven technologies with demonstrated value, and late adopters will begin integrating eClinical systems into their processes. Those already using ClinTech solutions will seek next-generation platforms that unify multiple workflows, reducing user fatigue and enhancing operational efficiency.</p>



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<p>Based on these predictions and existing trends, it seems likely that the ClinTech solutions space will converge around three key pillars in 2025:</p>



<p>1.<strong>&nbsp;Seamless integration of technologies:</strong>&nbsp;Unified platforms combining CTMS, EDC, eCOA, eConsent, and IRT.</p>



<p>2.<strong>&nbsp;Patient-first designs:</strong>&nbsp;Enhanced user experiences for diverse patient populations.</p>



<p>3.<strong>&nbsp;Proactive data utilisation:</strong>&nbsp;AI and machine learning for predictive modelling and decision-making.</p>



<p>The future of ClinTech solutions is bright, with innovation driving efficiency, inclusivity, and effectiveness in clinical trials. As 2025 evolves, these expert predictions, grounded in current data, suggest a rapidly maturing ecosystem that will redefine how we conduct research.</p>



<p>By embedding advanced technologies like AI and decentralised models, the clinical research industry is not only evolving but also setting a new standard for patient-centricity and operational excellence. The journey ahead promises an era of unprecedented innovation in clinical trials.</p>



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<h4 class="wp-block-heading" id="h-references"><strong>References</strong></h4>



<p>1.&nbsp;<strong>MarketsandMarkets.</strong>&nbsp;(2024). eClinical solutions market – Global forecast to 2029. MarketsandMarkets Research Report. Retrieved from&nbsp;<a href="https://www.marketsandmarkets.com/PressReleases/eclinical-solutions.asp" target="_blank" rel="noreferrer noopener">https://www.marketsandmarkets.com/PressReleases/eclinical-solutions.asp</a></p>



<p>2.&nbsp;<strong>Parkins, K., &amp; Hillman, A.</strong>&nbsp;(2021, December 14).&nbsp;<em>2022 forecast: Decentralised trials to reach new heights with 28% jump.</em>&nbsp;<em>Clinical Trials Arena.</em>&nbsp;Retrieved from&nbsp;<a href="https://www.clinicaltrialsarena.com/features/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump/" target="_blank" rel="noreferrer noopener">https://www.clinicaltrialsarena.com/features/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump/</a></p>



<p>3.&nbsp;<strong>Fultinavičiūtė, U., &amp; Maragkou, I.</strong>&nbsp;(2023, February 6).&nbsp;<em>DCT tracker update: Decentralised clinical trials to reach new peak</em>.&nbsp;<em>Clinical Trials Arena</em>. Retrieved from&nbsp;<a href="https://www.clinicaltrialsarena.com/news/dct-adoption-tracker-2023/" target="_blank" rel="noreferrer noopener">https://www.clinicaltrialsarena.com/news/dct-adoption-tracker-2023/</a></p>



<p>4.&nbsp;<strong>Chmielewska, I., &amp; Caruso, S.</strong>&nbsp;(2024, October 31).&nbsp;<em>Assessing current AI trends in drug development: Adoption and transformation (part 1)</em>. Norstella.&nbsp;<a href="https://www.norstella.com/assessing-current-ai-trends-drug-development-part-1/" target="_blank" rel="noreferrer noopener">https://www.norstella.com/assessing-current-ai-trends-drug-development-part-1/</a></p>



<p>5.&nbsp;<strong>Visiongain Reports Ltd.</strong>&nbsp;(2024, June 6).&nbsp;<em>Decentralised clinical trials market is estimated to grow at a CAGR of 7.6% by 2034.</em>&nbsp;<em>GlobeNewswire.</em>&nbsp;Retrieved from&nbsp;<a href="https://www.globenewswire.com/news-release/2024/06/06/2894920/0/en/Decentralised-Clinical-Trials-market-is-estimated-to-grow-at-a-CAGR-of-7-6-by-2034-Visiongain.html" target="_blank" rel="noreferrer noopener">https://www.globenewswire.com/news-release/2024/06/06/2894920/0/en/Decentralised-Clinical-Trials-market-is-estimated-to-grow-at-a-CAGR-of-7-6-by-2034-Visiongain.html</a></p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/clinical-technologies-expert-insights-and-predictions-for-2025/">Clinical Technologies: Expert Insights and Predictions for 2025</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC</title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/innovative-irt-solutions-almacs-commitment-to-clinical-trial-quality-and-innovation-in-apac/</link>
		
		<dc:creator><![CDATA[brendanhagan]]></dc:creator>
		<pubDate>Fri, 07 Feb 2025 13:06:07 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[IRT Clinical Trials]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=4092</guid>

					<description><![CDATA[<p>Joseph Goh Design Manager &#8211; 系统设计经理 &#124; Almac Clinical Technologies Introduction&#160; My name is Joseph, and I have been a Design Manager at Almac for almost eight years. I began my journey in Singapore, where I am originally from, but I have been based in Japan for over two years now.&#160; The Secret Behind Changi [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/innovative-irt-solutions-almacs-commitment-to-clinical-trial-quality-and-innovation-in-apac/">Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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<p><strong>Joseph Goh</strong></p>



<p><em>Design Manager &#8211; </em><em>系统设计经理 </em>|<em> Almac Clinical Technologies</em></p>



<p><strong>Introduction</strong>&nbsp;</p>



<p>My name is Joseph, and I have been a Design Manager at Almac for almost eight years. I began my journey in Singapore, where I am originally from, but I have been based in Japan for over two years now.&nbsp;</p>



<p><strong>The Secret Behind Changi Airport’s Success</strong>&nbsp;</p>



<p>As a Singaporean, I am proud of our world-class Changi International Airport, which has won top honors 12 times, including consecutively from 2013 to 2020. Achieving such success is not easy. One reason is the enforcement of high-quality, process-driven services. For example, Changi Airport customizes solutions and partnerships with airlines instead of using a one-size-fits-all model. This enables Changi Airport to drive air traffic and connectivity, maintaining its status as a premier air hub. The airport’s vision includes delivering the unique Changi Experience—a personalized, stress-free, and positively surprising journey. This means that airport facilities are constantly improved, renovated, or newly built to surpass customers’ and passengers’ expectations. This culture of excellence has kept Changi Airport as the top airport for many years. I share this success story to draw a comparison to why I believe Almac has remained one of the top IRT vendors in this field.</p>



<p><strong>The True Value of IRT Systems</strong>&nbsp;</p>



<p>In today’s world, IRT systems are constantly adding new features, functionalities, and boast fantastic-looking UIs. While these are important, how many features can we add? How robust should an IRT system be? And how cutting-edge should a UI look? While these features are now ubiquitous amongst IRT providers, a key differentiator that separates us from our competition is the process, service, and support that we can offer.</p>



<p><strong>Quality Starts from the Design</strong>&nbsp;</p>



<p>When I started as a Design Manager (DM), I was told the learning curve could be steep.  As the job involves detailed planning, quality design standards, and control. As a DM, we are well-trained to read and understand the study protocol to provide the best IRT design. New DMs are assigned a mentor for at least six months, receiving guidance from senior DMs during their first few studies. Just like how Changi Airport customizes solutions and partnerships with airlines, we engage in detailed discussions with clients to customize the system based on their study needs. There is no one-size-fits-all solution. </p>



<p>After discussing requirements with the client team, the design goes through two rounds of review—one through a requirement presentation to the Group Leader (GL) and Technical Service Leader (TSL), and another detailed requirement review. If any requirements are not up to par, the design managers must improve the design based on the reviewer’s comments. Due to stringent quality controls, this can translate into a substantial amount of work to be done within a short period. I did lose some sleep because of such high demands. However, these are to ensure the designs are of the highest quality before client sign-off.</p>



<p><strong>Not Just Typical Project Managers</strong>&nbsp;</p>



<p>When the APAC team first started out, DMs like us also held a hybrid role as PMs. We often joked that project managers (PMs) are our first and last line of defense. We were the first to receive the sometimes-difficult demands from our clients, and the last to enjoy the fruits of our work. PMs are the ones who hold and gel the team together, ensuring outstanding items are addressed timely, timelines are kept in check, and customers are kept happy.&nbsp;</p>



<p>PMs need to know how to interpret client expectations and require certain skills to read between the lines. Our PMs have years of experience and are skilled in client management. They build good relationships with the study team and have a solid technical knowledge of IXRS.  Years ago, during one of the Investigator Meetings in China, I was presenting the IXRS section, and during the Q&amp;A session, a question pertaining to drug supply was brought up. While I was answering the question, I mentioned the client’s internal standard which was not part of the scope of IXRS. During lunch, the client study manager expressed to me that he was impressed that an Almac PM was able to provide such detailed replies to the participants.</p>



<p><strong>Collaboration and Support in Development and Testing</strong>&nbsp;</p>



<p>Sometimes when I chat with our developers, they share that as developers, they do not work alone. From the start, a TSL is assigned to provide technical support and consultation. Code reviews are also done by TSLs to ensure complex or high-risk sections are properly and efficiently coded. Our testers then heavily test those codes, who are also assigned a GL for support and consultation. Features that do not pass testing will have bugs raised through a proper system to ensure resolution. During development and testing, DMs like myself, developers, and testers maintain constant communication to address any issues or improvements needed for the design.</p>



<p>In these eight years, thankfully, I only have a handful of studies that were considered highly complex. I remember one study that involved chemotherapy treatment, which had multiple titration rules and different combinations of chemotherapy options that impacted the visit schedule. The challenge for us was to make such a highly complex study simple to navigate and operate for the site users. During the development of that study, the developer had to explore different ways of coding to ensure the system could perform visit schedule switches along with the different chemotherapy. We also came together to discuss the different test scenarios and adjust the design accordingly to ensure the system was free from bugs. We too want to surpass the client’s expectations and give them a pleasant, worry-free experience using our system, just like what Changi Airport does.</p>



<p><strong>Quality Assurance: You Shall Not Pass?</strong>&nbsp;</p>



<p>When all development, internal testing, and UAT are completed, what stands between the system go-live is our outstanding team of Quality Assurance Analysts (QA). Holding the quality gate, QA analysts ensure that proper documentation, development tasks, and test case reviews check all the QC boxes. Any missing component will not pass the stringent QC process. Every checkbox must be checked.&nbsp;</p>



<p>Our QA team goes beyond acting as a gatekeeper for our development. We also have an Incident Report (IR) team that meticulously investigates any quality incidents, providing detailed reports on the causes and devising Corrective and Preventive Actions (CAPA). Their work helps us continuously identify shortcomings and improve our processes.&nbsp;</p>



<p>Of course, we must acknowledge our audit team, who play a crucial role in supporting audits and inspections. Whether it is a regulatory audit or a client request, our audit team consists of highly specialized staff who coordinate all documentation and interview requests. They ensure that audit inspections are conducted properly, documents are provided accurately, and all requests are meticulously tracked and documented. Their importance in helping us keep up to date and aligned with regulatory guidelines cannot be overstated.</p>



<p><strong>Our Own Team Success Story #1</strong>&nbsp;</p>



<p>In 2020, the pandemic broke out, causing significant challenges for several studies in China due to strict lockdown measures. As cities were under lockdown, it became difficult to provide drugs to patients, with hospitals also being inaccessible. One of our clients reached out to our Project Managers (PM), seeking ideas or solutions for this extraordinary situation. The PM organized a meeting with the client and included a consulting Design Manager (DM) to discuss potential solutions.&nbsp;</p>



<p>During the discussion, we concluded that the only viable option for the client’s operations was to ship the drug directly from the depot to the patient. Some studies were more complex, especially double-blinded studies involving numbered kits. Fortunately, it was an open-label (OL) study with non-numbered kits, allowing us to quickly devise a workaround. The process involved the drug supply manager moving the drug from the depot to the site using the adjust inventory feature. The site would then perform the visit transaction for the subject. Once completed, the site would request a specialized clinical logistics company to collect the drug from the depot and deliver it directly to the subject. With this workaround, we ensured that patients continued to receive their doses, and the study progressed smoothly without any further interruptions.&nbsp;</p>



<p>Although the workaround was simple, the meeting lasted over an hour as we needed to understand the client’s operational restrictions to provide the best solution for both the client and the patient. This pandemic level was unprecedented for everyone involved. However, using this experience as a learning opportunity, we enhanced our system by adding a “Direct Depot-to-Subject Visit Assignment” functionality.</p>



<p><strong>Our Own Team Success Story #2</strong>&nbsp;</p>



<p>Years ago, during one of our studies, a kit type that was being replaced, which was not brought to the attention of the IRT project manager. The new kit type had a different volume, affecting the actual quantity to be assigned. This required the system to assign a new kit type code and a system amendment to update the kit assignment logic. The situation was complicated by the fact that there were about five to six patients waiting for randomisation, and the transaction could not proceed because the new kit type could not be assigned. Given the difficulty in recruiting patients for this study, the client was keen to avoid turning them away.&nbsp;</p>



<p>Our PM called for a meeting with the client, and our team began working on a solution. By referencing the study randomisation records, we arranged a work around to have the subjects randomised until the system could be updated. Together with the client’s drug supply manager, we also assessed any subsequent drug dispensations that would be impacted, and came up with a mitigation approach, to avoid interruption in subject treatment. Our QA team ensured that these processes and deviations were properly recorded, documented and any potential regulatory concerns were addressed. This way, even in the event of an audit check, we could be confident that the process did not compromise the study’s integrity.&nbsp;</p>



<p>While these processes were ongoing, we quickly assembled a team for an emergency build release and worked tirelessly around the clock. Once the release went live, data in the IXRS was accurately injected to match all transactions. The entire process of adding the new kit type assignment logic and going live took less than a week, without compromising quality. All subjects were treated correctly, data integrity was maintained, recruitment was unaffected, and all unblinding information was securely preserved. While we do not consider ourselves superheroes, during that week, many of us felt like we were wearing study-saving capes.</p>



<p><strong>Conclusion</strong>&nbsp;</p>



<p>Finally, I would like to share some words from several client study managers:&nbsp;</p>



<ul class="wp-block-list">
<li><em>“Compared to another vendor, we felt much more secure entrusting this study with Almac.”</em></li>



<li><em>“The knowledge you have of our internal processes was a pleasant surprise. This shows the quality of Almac.”</em></li>



<li><em>“Any study with Almac IRT is worry-free. UAT is the smoothest sailing compared with other vendors.”</em>&nbsp;</li>
</ul>



<p>These testimonials from our valued customers are a tremendous encouragement to us. The success of both Changi Airport and Almac is built on a shared commitment to quality and continuous improvement. Changi Airport’s excellence in the aviation industry and Almac’s unique approach to development processes ensure we deliver reliable IRT solutions.&nbsp;</p>



<p>Our process is distinctive in its meticulous understanding of client needs, rigorous multi-layered quality control, and a culture of open communication and continuous learning. These unique elements are integral to our operations and have earned us the trust and loyalty of our clients. As we continue to innovate and uphold these high standards, we are confident in our ability to provide exceptional service and maintain our leadership in the field. For more information regarding Almac’s APAC IRT Regional Capabilities and for more information on our commitment to delivering quality services to our customers, visit our website: <a href="https://www.almacgroup.com/clinical-technologies/asia-pacific-apac-irt-regional-capabilities/">Almac’s Asia-Pacific (APAC) IRT Regional Capabilities</a></p>



<p><a id="_msocom_1"></a></p>



<p></p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/innovative-irt-solutions-almacs-commitment-to-clinical-trial-quality-and-innovation-in-apac/">Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC &#8211; Chinese</title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/innovative-irt-solutions-almacs-commitment-to-clinical-trial-quality-and-innovation-in-apac-chinese/</link>
		
		<dc:creator><![CDATA[brendanhagan]]></dc:creator>
		<pubDate>Fri, 07 Feb 2025 13:05:58 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[IRT Clinical Trials]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=4090</guid>

					<description><![CDATA[<p>革新的 IRT 解决方案：Almac 对在亚太地区临床实验质量与创新的承诺 Joseph Goh &#8211; Design Manager &#8211; 系统设计经理 &#124; Almac Clinical Technologies 简介 我是 Joseph，在 Almac 担任系统设计经理近八年。我来自新加坡，并在此开启了我的职业生涯，但我现在已在日本工作超过两年。 樟宜机场成功背后的秘密 作为一名新加坡人，我为我们的樟宜国际机场深感自豪。樟宜机场于2013 至 2020 年连续八年蝉联全球最佳机场，共12次荣膺桂冠。这份骄人成绩的背后，是对以流程为导向的高品质服务的坚持。例如，樟宜机场与各航空公司定制解决方案和合作伙伴关系，而非使用通用模式。这有助于樟宜机场推动航空交通和连通性，保持其一流航空枢纽的地位。机场的愿景包括提供独到的樟宜体验——打造个性化、轻松无忧、充满惊喜的旅程。这意味着需要不断改进、更新或新建机场设施，从而超越客户和乘客的期待。樟宜机场的卓越文化使其多年来始终保持一流机场的地位。我举这个例子也是为了说明，为什么 Almac 能始终保持 IRT 优质供应商的地位。 IRT 系统的真正价值 当前，IRT 系统不断增加新的特性和功能，并拥有美轮美奂的用户界面。这些固然重要，然而，我们需要思考的是：系统功能究竟可以扩展到何种程度？IRT 供应商提供的核心功能大同小异， 真正让 Almac 脱颖而出，区别于竞争对手的一个关键因素是我们能够提供的流程、服务和技术支持。 质量始于设计 初任系统设计经理 (DM) 时，我被告知这个岗位需要学习相当长一段时间才能完全胜任，因为它涉及周密的规划、严格的设计标准以及全方位的质量管控。作为 DM，我们不仅需要通过系统化培训，更要具备深入理解研究方案的能力，才能设计出最优的 IRT 解决方案。在最初的学习中，我们会为新 DM 分配一位导师，在至少六个月的时间内，高级 DM 将为其提供指导。正如樟宜机场与各航空公司定制解决方案和合作关系，我们也与客户进行详细讨论，根据客户的研究需求定制系统，而不是使用通用的解决方案。 与客户团队讨论相关要求后，会对设计进行两轮审查——一轮是对小组负责人 (GL) 和技术服务负责人 (TSL) 进行要求展示，另一轮是详细的要求审查。如果任何要求没有达到标准，系统设计经理必须根据审查者的意见做出改进。由于严格的质量控制，这意味着需要在短时间内完成大量工作。我因为这些高要求牺牲过一些睡眠时间。但是，这是为了确保设计在客户签署确认之前达到最高质量。 不仅是常规的项目经理 当亚太团队刚刚起步时，我们 [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/innovative-irt-solutions-almacs-commitment-to-clinical-trial-quality-and-innovation-in-apac-chinese/">Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC &#8211; Chinese</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
]]></description>
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<h2 class="wp-block-heading" id="h-革新的-irt-解决方案-almac-对在亚太地区临床实验质量与创新的承诺">革新的 IRT 解决方案：Almac 对在亚太地区临床实验质量与创新的承诺</h2>



<p><strong>Joseph Goh &#8211; </strong><em>Design Manager &#8211; 系统设计经理 </em>|<em> Almac Clinical Technologies</em></p>



<p><strong>简介</strong></p>



<p>我是 Joseph，在 Almac 担任系统设计经理近八年。我来自新加坡，并在此开启了我的职业生涯，但我现在已在日本工作超过两年。</p>



<p><strong>樟宜机场成功背后的秘密</strong></p>



<p>作为一名新加坡人，我为我们的樟宜国际机场深感自豪。樟宜机场于2013 至 2020 年连续八年蝉联全球最佳机场，共12次荣膺桂冠。这份骄人成绩的背后，是对以流程为导向的高品质服务的坚持。例如，樟宜机场与各航空公司定制解决方案和合作伙伴关系，而非使用通用模式。这有助于樟宜机场推动航空交通和连通性，保持其一流航空枢纽的地位。机场的愿景包括提供独到的樟宜体验——打造个性化、轻松无忧、充满惊喜的旅程。这意味着需要不断改进、更新或新建机场设施，从而超越客户和乘客的期待。樟宜机场的卓越文化使其多年来始终保持一流机场的地位。我举这个例子也是为了说明，为什么 Almac 能始终保持 IRT 优质供应商的地位。</p>



<p><strong>IRT </strong><strong>系统的真正价值</strong></p>



<p>当前，IRT 系统不断增加新的特性和功能，并拥有美轮美奂的用户界面。这些固然重要，然而，我们需要思考的是：系统功能究竟可以扩展到何种程度？IRT 供应商提供的核心功能大同小异， 真正让 Almac 脱颖而出，区别于竞争对手的一个关键因素是我们能够提供的流程、服务和技术支持。</p>



<p><strong>质量始于设计</strong></p>



<p>初任系统设计经理 (DM) 时，我被告知这个岗位需要学习相当长一段时间才能完全胜任，因为它涉及周密的规划、严格的设计标准以及全方位的质量管控。作为 DM，我们不仅需要通过系统化培训，更要具备深入理解研究方案的能力，才能设计出最优的 IRT 解决方案。在最初的学习中，我们会为新 DM 分配一位导师，在至少六个月的时间内，高级 DM 将为其提供指导。正如樟宜机场与各航空公司定制解决方案和合作关系，我们也与客户进行详细讨论，根据客户的研究需求定制系统，而不是使用通用的解决方案。</p>



<p>与客户团队讨论相关要求后，会对设计进行两轮审查——一轮是对小组负责人 (GL) 和技术服务负责人 (TSL) 进行要求展示，另一轮是详细的要求审查。如果任何要求没有达到标准，系统设计经理必须根据审查者的意见做出改进。由于严格的质量控制，这意味着需要在短时间内完成大量工作。我因为这些高要求牺牲过一些睡眠时间。但是，这是为了确保设计在客户签署确认之前达到最高质量。</p>



<p><strong>不仅是常规的项目经理</strong></p>



<p>当亚太团队刚刚起步时，我们 DM 还同时兼任项目经理 (PM) 的角色。我们经常开玩笑说，项目经理是我们的第一道也是最后一道防线。我们是第一个收到客户要求的人（偶尔是很棘手的要求），也是最后一个享受工作成果的人。PM 将团队凝聚在一起，确保及时解决出现的问题，把控时间线并让客户满意。</p>



<p>PM需要理解客户在沟通中提出的明确需求，也需要一定的技能来揣摩客户文字背后更深层次的其他需求。我们的 PM 拥有多年的经验，擅长客户管理。他们与研究团队构建了良好的合作关系，有扎实的 IXRS 技术知识。多年前，我代表 IXRS 部门出席在中国举办的一场研究者会议，在问答环节，与会者提出了一个与药物供应相关的问题。当我回答问题时，我提到了客户的内部标准，这并不属于 IXRS 范围。午餐时，客户的研究经理对我说，Almac PM 能向与会者提供如此详尽的回答，令他印象深刻。</p>



<p><strong>开发和测试中的合作与支持</strong></p>



<p>在与开发团队交流时，他们常说在 Almac，开发从来都不是一个人的战斗。每个项目伊始，都会配备技术服务负责人 (TSL) 提供专业支持和技术指导。TSL 不仅参与日常咨询，还会对代码进行严格审查，特别是确保那些复杂度高、风险等级大的模块得到最优化处理。我们的测试人员对这些代码进行了大量测试，公司也为此分配了一位 GL 提供支持和咨询。未通过测试的特性将通过适当的系统提出缺陷，确保得到解决。在开发和测试期间，我们 DM、开发人员和测试人员不断沟通，解决问题或进行设计所需的改进。</p>



<p>幸运的是，八年来，我只遇到过少数极为复杂的研究。我记得其中一项研究涉及化疗，其中有多个剂量调整规定和不同的化疗方案组合，会对访视时间表产生影响。我们面临的挑战是，需要把这个高度复杂的研究设计得易于研究中心用户导航和操作。在研究开发期间，开发人员需要探索不同的编码方式，确保系统能针对不同的化疗切换访视时间表。我们还聚在一起讨论不同的测试场景并对设计做出相应调整，确保系统没有漏洞。像樟宜机场一样，我们也想超越客户的期待，为他们提供轻松愉快的系统使用体验。</p>



<p><strong>质量保证：不能通过？</strong></p>



<p>系统正式上线前，即便已完成全部开发工作、内部测试和用户验收测试 (UAT)，还需经过我们严谨的质量保证分析员 (QA) 团队把关。QA 团队恪守质量准则，严格审核所有文档、开发任务和测试用例，确保每一个环节都达到质量控制的最高标准。如有任何偏差，系统都无法通过这道严格的质量检验。</p>



<p>我们的 QA 团队不仅为我们的开发担任把关者，我们还有一支事件报告 (IR) 团队，会一丝不苟地调查任何质量事件，对原因提供详细报告并制定纠正和预防措施 (CAPA)。他们的工作帮助我们不断识别缺陷，改进我们的流程。</p>



<p>当然，我们必须承认我们的审计团队在支持审计和检查方面发挥了关键作用。我们的审计团队由精专人才组成，可以协调所有文件和面试要求——无论是常规审计还是客户要求的审计。他们确保顺利进行审计检查，准确提供文件，仔细跟踪和记录所有要求。他们帮助我们与时俱进，遵守至关重要的监管指南。</p>



<p><strong>我们的团队成功案例</strong><strong> 1</strong></p>



<p>2020 年新冠疫情爆发，中国各地实施严格的疫情管控措施，医院很难向患者提供药物，患者也难以进入医院。这给我们在中国正在进行的多项临床研究带来了前所未有的挑战。我们的一位客户联系到我们的项目经理 (PM)，寻求应对这种特殊情况的意见或解决方案。这位 PM 组织了一场客户会议，并请一位系统设计经理作为顾问来讨论潜在的解决方案。</p>



<p>讨论得出的结论是，就客户开展研究而言，唯一可行的选择是将药物直接从仓库寄给患者。一些研究更为复杂，尤其是涉及编号药盒的双盲研究。幸运的是，我们刚才提到的这项研究是开放性 (OL) 研究，无需对药盒进行编号，因此我们可以快速设计出应对方法。这一过程涉及药物供应管理者使用调整库存功能，将药物从仓库送往研究中心。然后研究中心为受试者进行访视操作。完成之后，研究中心将聘用专业的临床物流公司将研究药物直接从仓库送达受试者。使用此方法，我们确保患者可以继续用药，研究顺利开展，没有再被中断。</p>



<p>虽然应对方法很简单，但是这场会议持续一小时，因为我们需要了解客户的运营限制，从而提供兼顾客户和患者的优选解决方案。此次疫情规模对于大家来说前所未有。然而，我们将此次经历作为学习机会，新增“仓库直达受试者访视分配”功能，增强了我们的系统。</p>



<p><strong>我们的团队成功案例</strong><strong> 2</strong></p>



<p>很多年前在我们的一项研究中，一种药盒类型被替换了，但是没有引起 IRT 项目经理的注意。新的药盒类型体积有变，影响了实际分配的药量。这需要系统分配新的药盒类型代码和系统修改，来更新药盒分配逻辑。当时有五六名患者正在等待随机分配，而因为新的药盒类型无法分配导致操作无法进行，让情况变得很复杂。由于此研究招募患者很难，因此客户竭力避免患者流失。</p>



<p>我们的 PM 与客户召开了会议，我们的团队开始研究解决方案。通过参阅研究随机分配记录，我们制定了应对方法，让受试者完成随机分配，直到系统可以更新。我们还与客户的药物供应经理评估后续可能受到影响的药物分发，并找到缓解方法，避免影响受试者治疗。我们的 QA 团队确保这些流程和偏离得到妥善记录、存档并解决任何潜在的监管问题。这样，即使面临稽查检查，我们也有把握确保流程不会破坏研究的完整性。</p>



<p>在这些流程进行期间，我们会快速组建一个团队进行紧急版本发布，争分夺秒地工作。发布版本上线后，向 IXRS 中输入正确数据，匹配所有操作。添加新药盒类型分配逻辑和版本上线的整个流程用时不到一周，质量没有受到影响。所有受试者都接受了正确治疗，维护了数据完整性，招募工作没有受到影响，所有揭盲信息都得到了安全保护。虽然我们并没有认为自己是超级英雄，但在那一周，我们中的很多人都感觉自己身披拯救研究的斗篷。</p>



<p><strong>结论</strong></p>



<p>最后，我想分享来自几位客户研究经理的一些评价：</p>



<ul class="wp-block-list">
<li><em>“与其他供应商相比，我们感觉把研究交给 Almac 更让人放心。”</em></li>
</ul>



<ul class="wp-block-list">
<li><em>“Almac 对我们内部流程的了解着实让我惊喜。这也展现了 Almac 的品质。”</em></li>
</ul>



<ul class="wp-block-list">
<li><em>“使用 Almac IRT 开展的任何研究都不用担心。与其他供应商相比，Almac 的 UAT 尤为顺畅。”</em></li>
</ul>



<p>这些评价来自我们的重要客户，对我们而言是莫大的鼓励。樟宜机场和 Almac 的成功都源于对质量和不断提升的追求。如同樟宜机场在航空业的卓越表现，Almac 对开发流程的独特方法确保我们提供可靠的 IRT 解决方案。</p>



<p>我们流程的不同之处在于我们细致了解客户需求，严格执行质量控制，践行开诚布公和不断学习的文化。这些独特元素是我们开展业务的必要部分，为我们赢得了客户的信任与忠诚。随着我们不断创新并坚持这些高标准，我们相信自己能够提供卓越的服务并保持我们在行业内的领导地位。</p>



<p>如需详细了解 Almac 在亚太地区的 IRT 能力以及我们致力于为客户提供优质服务的承诺，请访问我们的网站：Almac 在亚太区的卓越成就与战略部署</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/innovative-irt-solutions-almacs-commitment-to-clinical-trial-quality-and-innovation-in-apac-chinese/">Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC &#8211; Chinese</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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		<title>Putting trial data insights into action for your study</title>
		<link>https://www.almacgroup.com/clinical-technologies/blogs/putting-trial-data-insights-into-action-for-your-study/</link>
		
		<dc:creator><![CDATA[brendanhagan]]></dc:creator>
		<pubDate>Fri, 01 Nov 2024 14:18:46 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.almacgroup.com/clinical-technologies/?p=3991</guid>

					<description><![CDATA[<p>Putting trial data insights into action for your study Amanda MacGregor Product Manager, Strategic Solutions Data Integrity (complete, consistent, and accurate data) must be maintained throughout a clinical trial. Current guidance aims to not only assure data integrity, but to take a more proactive approach, documenting how data will be monitored throughout the clinical trial. [&#8230;]</p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/putting-trial-data-insights-into-action-for-your-study/">Putting trial data insights into action for your study</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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<h1 class="wp-block-heading has-medium-font-size" id="h-putting-trial-data-insights-into-action-for-your-study">Putting trial data insights into action for your study</h1>



<p><strong>Amanda MacGregor</strong></p>



<p><em>Product Manager, Strategic Solutions</em></p>



<p>Data Integrity (complete, consistent, and accurate data) must be maintained throughout a clinical trial. Current guidance aims to not only assure data integrity, but to take a more proactive approach, documenting how data will be monitored throughout the clinical trial. Ensuring your trial has a data monitoring plan in place will provide a mechanism to meet regulatory guidance and maintain data integrity.</p>



<p>The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) revised guidance requires documented evidence on how the sponsor performed surveillance of the study. The Data Integrity guidance put out by the MHRA, FDA, and theEMA aimed to not only assure data integrity but to enhance and take a more proactive approach. When developing a rigorous data monitoring plan, a solution must be incorporated to perform the necessary data reviews. This could involve manual data exporting and verification across multiple eclinical solutions if an integrated solution is not in place.</p>



<h2 class="wp-block-heading has-medium-font-size" id="h-what-should-be-considered-in-a-data-monitoring-plan">What should be considered in a data monitoring plan?</h2>



<p>Periodic reviews of this data will ensure data integrity is maintained. The IXRS® is a critical control point, as in many instances, it is the first point of entry of data. As such, this data is ultimately pushed to other systems (EDC, eCOA, CTMS). Our system, the IXRS, is often used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.</p>



<h2 class="wp-block-heading has-medium-font-size">What tools are available to support data monitoring?</h2>



<p><strong>&nbsp;</strong>Reports and integrations play a crucial role in a data monitoring plan. While data is generally accessible through reports, it must be organized effectively for the periodic reviews and monitoring being performed. Otherwise, additional effort is needed to analyze the data, which is essential for identifying initial entries and any subsequent changes which are part of an audit trail. This analysis helps in spotting trends or potential concerns. Additionally, capturing historical data updates—such as who made changes and when— is vital for comprehensive monitoring.</p>



<p>OVERSIGHT™, Almac’s data monitoring tool, is a suite of analytic reports which automatically organizes the IRT data and transaction history for ease of data integrity reviews, audit trail reviews and data monitoring.</p>



<p>Almac’s OVERSIGHT™ solution will help identify anomalies such as sites making high risk data edits, too many data adjustments, or unexpected system transactions. OVERSIGHT™ enables our users the ability to filter and organize data on-demand, directly within the IXRS®. Having access to a summarized view of how many events occurred in the study, at which location, and what data change was performed, allows for easily identifying trends and potential irregularities.</p>



<h2 class="wp-block-heading has-medium-font-size" id="h-how-will-data-monitoring-benefit-my-trial">How will data monitoring benefit my trial?</h2>



<p>Proactive and ongoing data review is expected by regulators.&nbsp; Identifying anomalies, such as high-risk data edits, too many data adjustments, or unexpected system transactions, empowers sponsors to maintain control of the data integrity of their trial. With Increased regulatory guidance and recommendations in this area, incorporating sufficient tools to support monitoring and inspection requests is essential.</p>



<p>It is important to enable our Sponsors to make informed, risk-based decisions on the usage of the IXRS®. Providing real time, on-demand visibility into the data is key. OVERSIGHT™ will aid clients to identify data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews.&nbsp; &nbsp;</p>



<h2 class="wp-block-heading has-medium-font-size">How else can a data monitoring plan be used?</h2>



<p>There have been increases in inspection support requests, which may include agency audits. &nbsp;Recent examples include a focus on IRT data such as:</p>



<ul class="wp-block-list">
<li>History of Site activations/activities</li>



<li>Data updates to IRT for incorrect dispensation</li>



<li>Audit Trail Review</li>



<li>Report of Kit assignments, Investigation into kit assignments and anomalies (Site errors)</li>



<li>Kit/Patient Reconciliation, System Confirmations</li>
</ul>



<p>In many instances, the IXRS®3 acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS). Our system can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial, thus ensuring data integrity is maintained throughout.&nbsp; Adopting a data monitoring plan will ensure you can have a process in place to identify anomalies in the data and take the necessary steps to correct the issues before they become a much bigger problem.</p>



<p>For more information regarding Almac’s OVERSIGHT™ offering, check out:</p>



<p><a href="https://www.almacgroup.com/clinical-technologies/irt-boosters/oversight/">OVERSIGHT Trial Data Integrity Monitoring System &#8211; Almac (almacgroup.com)</a></p>
<p>The post <a href="https://www.almacgroup.com/clinical-technologies/blogs/putting-trial-data-insights-into-action-for-your-study/">Putting trial data insights into action for your study</a> appeared first on <a href="https://www.almacgroup.com/clinical-technologies">Clinical Technologies</a>.</p>
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