Post SCOPE: Expert Insights and Predictions for the rest of 2026
Duncan McDonald, eClinical Solutions Advisor | Almac Clinical Technologies
Over the past decade, clinical research has undergone one of the most profound technological transformations in its history. Legacy digital systems and point solutions have evolved into today’s landscape of integrated platforms, advanced analytics, decentralized execution, and early applications of artificial intelligence (AI). Looking ahead, the pace of innovation will continue, but with greater emphasis on efficiency, interoperability, regulatory alignment, and pragmatic value creation.
In this commentary, we highlight four defining trends that will shape clinical technologies in 2026 and beyond. These trends reflect where the industry is today, where it’s rapidly headed, and the governance frameworks that will ensure these advances drive better outcomes for patients and sponsors alike.
AI Enters the Mainstream: From Novelty to Operational Imperative
Artificial intelligence has shifted from conceptual promise to operational reality in many areas of clinical research. Today, AI is being used to optimize trial design, accelerate site feasibility analysis, personalize patient recruitment strategies, and enhance data cleaning and monitoring workflows. What was once experimental is now increasingly embedded within day-to-day operations.
However, as AI becomes more mainstream, it is essential to recognize that its integration must be guided by responsibility, accountability, and above all, ethical principles. The benefits of AI can only be fully realized when its use is not only transparent and 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.
Regulators are responding in parallel: the U.S. Food and Drug Administration (FDA) has issued guidance emphasizing 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.
Almac Insight – Mike Hutton, Director – Strategic Partnerships & Commercialization:
“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, validated, and clearly aligned with patient safety and regulatory expectations. 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.”
Decentralized and Hybrid Trials Become the Norm
Decentralized clinical trial (DCT) models are no longer driven by necessity alone, 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.
Technologies such as electronic consent, remote data capture, and wearable devices are now widely accepted across regulatory jurisdictions. However, decentralization introduces new complexities, particularly around data integration, operational oversight, and consistency across geographies.
Almac Insight – Abi Pesun, Vice President, Operations:
“Decentralization works best when it is intentional rather than reactive. The real challenge, and opportunity, lies in designing hybrid models that respect patient preferences while maintaining operational clarity and data integrity across the entire study.”
Interoperability and Platform Integration Reduce Technology Burden
One of the most persistent challenges in clinical operations remains technology fragmentation. Sponsors and CROs often rely on multiple systems across eCOA, RTSM, EDC, eTMF, and analytics, creating unnecessary complexity and manual reconciliation.
Throughout 2026, the industry will increasingly prioritize integrated, interoperable platforms that provide a single source of truth, reduce administrative burden, and enable real-time, cross-functional insights. This shift is not just about IT efficiency, it directly impacts study timelines, data quality, inspection readiness, and team productivity.
Almac Insight – Cheryl Kole, Vice President, Strategy and Commercialization
“Interoperability is no longer a ‘nice to have’. Sponsors want solutions that work together by design, not through layers of custom integration. Reducing tech burden ultimately frees teams to focus on science rather than systems.”
Regulatory Alignment in a Digital-First Clinical Environment
As technology advances, regulatory frameworks are evolving to ensure innovation is underpinned by robust governance. Both the FDA and EMA are expanding guidance around digital evidence, real-world data, AI-enabled decision support, and quality systems, reinforcing the importance of traceability, validation, and lifecycle oversight.
This year’s success will depend on selecting technologies that are not only innovative, but designed with regulatory expectations in mind, enabling sponsors to scale digital approaches with confidence rather than caution.
Almac Insight – Matthew Lowrie, Director, QA & Regulatory Compliance
“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.”
Practical Innovation at the Intersection of Technology and Trust
The most impactful clinical technologies this year will not be defined by novelty, but by usability, integration, and governance readiness. AI will become embedded rather than experimental. Decentralized 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.
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 center of innovation.
Disclaimer:
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”).
Almac is committed to the ethical and responsible exploration of new and emerging technologies. We prioritize rigorous internal evaluation, validation, and continuous improvement to ensure that all current and future solutions are trusted, reliable, and regulatory-ready.
