Integrating the digital and physical supply chain: Optimal performance, reduced risks, and lower costs

By Jonathan Cousins and Claire Voigt

The pharmaceutical industry’s current drug development system is “in crisis and unsustainable”, according to the Clinical Trials Transformation Initiative (CTTI), a public-private partnership in the US to improve the quality and efficiency of clinical trials.1 The organization has, over the past few years, issued multiple sound recommendations for Sponsors and Contract Research Organizations (CROs) on a range of trial processes—from recruitment planning to data monitoring.

Meanwhile, Sponsors and CROs are actively pursuing various trial innovations that can ultimately lead to a competitive advantage in the market. However, there is a frequent source of inefficiency in clinical trial operations that is often overlooked: the lack of coordination between the digital and the physical supply chain of drug delivery to trial sites.

The integrated supply chain

The pharmaceutical industry is accustomed to thinking of the clinical trial supply chain as having two distinct parts: the digital supply chain, meaning the technology required to manage and monitor drug inventory, and the physical supply chain, or the processes involved in preparing and shipping drug products from depots to sites. That delineation was created—and is now perpetuated—not for any process-related reason, but rather simply because most vendors supporting the industry provide only half of the equation.

The delineation between the digital and physical supply chain need not exist; ideally, it should not exist. The digital and physical aspects of the supply are inexorably linked across all phases of the trial, starting with forecast and moving onto the bulk input and preparation of finished goods ready to ship from the depot… to monitoring sites’ inventory and patient dispensing… to managing returns and accounting for the disposition of all products. There are significant interdependencies between the Interactive Response Technology (IRT) and the management services needed to ensure that the right drug is available at the right site at the right time, and for the lowest cost.

The extent to which the supply chain technology and supporting services are integrated directly affects the amount of oversight, degree of alignment, number of custom system integrations and level of risk involved in ensuring successful trial operations. A greater coordinated effort will lead to more visibility into what is happening and thus enable the trial manager to meet the trial demands in a more cost-effective, streamlined way. Conversely, executing the optimal supply chain strategy is more difficult, expensive, and time-consuming when different vendors are working independently.

When trial Sponsors turn to separate partners to support the digital and physical supply chain, they must necessarily commit to spending significant management time serving as a go-between. The onus is on the Sponsor to ensure that the lines of communication are open between all of the parties, which usually translates into more frequent meetings.

Having multiple vendors also contributes to a fragmented financial picture. As explained by Heather Schultz in an Applied Clinical Trials article, “Multiple vendors and contracts end up in disparate systems, and the lack of integration doesn’t allow that data to be brought together for financial management in an easy or efficient way, making forecasting and budgeting extremely challenging.”

The complexity of problem resolution also increases with the number of vendors involved in the project. Multiple information sources and the limited view of each vendor make root cause analysis difficult. Also, it is easy for individual vendors to lapse into absolving themselves, pinning the “blame” for issues on others.

Finding a workable resolution can, therefore, be frustrating and time-consuming. In contrast, when a single vendor team is involved throughout the project, there can be a single, cross-team escalation pathway that tends to speed problem resolution.

Alignment, coordination, and consistency

The above project oversight issue has easy remedies but can require costly investment with the help of additional management resources. However, the need to ensure that all parties are in alignment and are working toward a common goal using consistent approaches is a much more serious matter.

A common understanding of the strategy is essential to seeing that the IRT design, packaging design, and distribution strategy all are working together in a cohesive fashion. Costly inefficiencies arise when elements are misaligned. Investigational Medicinal Product (IMP) may sit at the depot long before the IRT is configured, or vice versa. The IRT may generate shipments that are impractical for sites to cope with logistically or that are not in line with the average patient’s treatment needs. Each vendor may create its own, unrelated set of requirements that cannot be easily integrated with others, posing difficulties for supply monitoring and data analysis. And the list goes on.

Vendor responsibility is limited to the portion of the overall trial they have visibility to. Therefore, ensuring that overarching protocol objectives are met rests with the study Sponsor. Ensuring that cross-discipline goals, timelines, processes, and deliverables align across vendors is a time-consuming and challenging endeavor. Efficiencies in Clinical Trial delivery translate into increased quality and decreased cost.

To find out more about Almac ONE, click here.

1 http://www.ctti-clinicaltrials.org/home

Barring the Electronic Door: How to Secure Mobile Devices Used in Clinical Trials

By Richard Wzorek

In the foreseeable future, biopharmaceutical companies that do not allow those working on clinical trials to have mobile access to the systems and data they need will be at a competitive disadvantage.

Internal users, investigator sites, Clinical Research Organizations (CROs), central labs, and other vendors all have a growing expectation that they can access trial data and applications “where they live,” in other words, on their mobile devices. Indeed, worldwide usage trends and prospective productivity gains make a compelling case for moving in a mobile direction. However, some inherent security risks complicate the landscape significantly, and decision-makers should proceed with their eyes wide open. Here, we discuss the leading security risks to consider and offer recommendations on how to mitigate or avoid them.

The case for mobile access

Mobile devices are now ubiquitous, with their usage long since eclipsing that of desktop devices. The crossover happened in 2014, and the gap continues to widen in favor of mobile computing.1 What is more, over the past five years, there has been a substantial increase in the number of Internet users who rely exclusively on mobile devices.2

Cisco Systems was forecasting that by 2019, about 24 exabytes (a billion gigabytes) of data will be transferred to and from mobile devices each month.3 To put this intangible number into perspective, consider that a single Exabyte could transmit 119 billion songs that would last for 906,000 years.4

Between 2012 and 2015 there has been double-digit growth in the number of clinical trials in most regions of the world. The Asia Pacific region has seen material clinical trial growth led by countries like China (71%), Japan (54%), and India (37%). This growth in clinical trial volume is from the region that is forecasted to have the most significant mobile data volume over the next five years.

Given the popularity of mobile devices, it is no wonder that those involved with clinical trials—and most especially clinical investigators—would prefer to have the information and tools that they need to do their jobs accessible on smartphones and tablets. For instance, it is much more efficient for investigators to be able to work with clinical trial tools that are embedded in their workflow for providing the standard of care than it is for them to have to switch systems and transport data from one device to another.

Healthcare institutions have captured the attention of cybercriminals for several reasons:

  • The exchange of electronic healthcare information is a relatively recent phenomenon, and many institutions are still soft
  • Healthcare databases contain vast amounts of Personally Identifiable Information (PII) that doesn’t “expire.”
  • Credit card and bank account data present only a narrow window of opportunity—i.e., typically the theft is discovered and the breach remedied quickly. Meanwhile, medical information fraud can go undetected for quite some
  • Many financial services institutions and retailers have developed some expertise and experience in thwarting attacks, so criminals turn their attention
  • The value of stolen healthcare data is at a
  • According to the World Privacy Forum, hackers and identity thieves will pay $50 for stolen medical information versus $1 for a stolen Social Security 5

The sources of risk: BYOD and outside networks

Bring Your Own Device (BYOD) solutions

At first blush, allowing those involved in clinical trials to use their own existing mobile devices (smart phones and tablets) for trial work and participation seems like a financial “no brainer.” Why provision and then have to maintain and manage proprietary devices when parties already have the hardware themselves? It is not as simple as it sounds, however. The main issue relates to the number of device platforms that would have to be supported, particularly for global trials. Not only is there the matter of Android versus Apple operating systems, but there are multiple releases of each on the market. (This is especially true in Latin America where the secondary market for used devices is very strong.) Not all will have the latest security patches.

Public hotspots and guest networks

Data residing on a device that is used in a public place—whether it be as an executive checks e-mail in a café, or as a study monitor reviews files at an airport— are at risk for being compromised. Usually, however, the device itself and the information on it are not the hacker’s ultimate target. Rather, hackers troll such networks in an attempt to use the mobile device as a vector to gain access to an organisation’s internal network.

Allow us to secure your mobile devices used in clinical trials through OVERSIGHT.

To find out more about OVERSIGHT, click here.

1 http://www.marketingcharts.com/ online/in-the-us-time-spent-with mobile-apps-now-exceeds-the- desktop-web-41153/
2 http://www.marketingcharts.com/ online/us-now-sees-more-mobile- only-than-desktop-only-adult- internet-users-54072/
3 http://www.cisco.com/c/en/us/ solutions/collateral/service-provider/ visual-networking-index-vni/white_ paper_c11-520862.html
4 http://www.scality.com/100- exabytes-makes-big-data-look-tiny/
5 https://www.worldprivacyforum.org/2006/05/report-medical-identity-theft-the-information-crime-that-can-kill-you/

Are you equipped with an inspection-ready IRT?

In the race to improve speed and efficiency in drug development, clinical research studies have grown dramatically in the last decade in both numbers and complexity. Adaptive design, multiple cohorts, randomization and detailed dosing instructions have been driving factors in this increase as sponsors are looking to achieve more endpoints within a single protocol.

As companies continue to collect higher volumes of data in an effort to shorten the duration and number of trials required for submission, it becomes increasingly difficult for researchers to manage this information. This means the toolsets used to conduct studies are being relied upon more heavily. At the same time, the pharmaceutical landscape continues to shift toward large molecule compounds, where a unique set of challenges is emerging. Compared to small molecule drugs, biologics are more sensitive to temperature shifts, making supply chain management increasingly difficult.

Additionally, not only are there higher costs to manage when developing a biologic, but also the submission of a Biologics License Application (BLA) is subject to higher scrutiny by regulatory agencies. Therefore, biologics inherently require an increased focus on Interactive Response Technology (IRT) processes by regulators, as the data collected in an IRT is crucial to support a regulatory submission. This is why now, more than ever, the FDA is taking a closer look at IRTs and how these systems can directly impact patient safety and clinical trial integrity. The obvious conclusion is that the partner chosen to provide the technology to assist with these challenges must be up for the task.

In today’s pharmaceutical market, nearly 20 percent of total sales are biologics. By 2020, it was expected that they will make up slightly more than half of the world’s top 100 selling drugs. As we move toward the future, the industry will look to technologies like IRT to meet the needs of the trials that will bring these drugs to market. In the competitive pool of IRT providers that have developed during the system’s evolution, how many will be able to offer the technologies, design, and experience to do this successfully?

FDA expectations of an IRT system

The IRT system captures the broader features emerging within the market, such as electronic-reported outcomes, titration/dosing calculations, shamming (blinding of patient labs or other results), supply accountability, reconciliation, and returns. It can ensure the drug is at the right place, at the right time, and in the right quantities with the ability to respond to any changes throughout the course of the trial. The information collected and generated in an IRT system is at the center of some of the most critical aspects of a clinical trial, such as:

  • Integrity of randomization, implementation, and stratification of data
  • Dosing calculations and/or titration rules
  • Supply management aspects, such as control of expiring drugs, tracking of temperature excursions, and management of recalls

Beyond these, an IRT system improves the visibility that sponsors have into how sites are performing. For this reason, the FDA expects it to be used as a way to provide proper oversight of a clinical trial and to identify and remediate issues in a timely manner.

There are many vendors trying to use IRT in a very simplistic way and focusing solely on randomization and supply management. However, IRT saves time and money across many aspects of trial execution, and it has the potential to do even more. The use of analytics from IRT to support risk-based monitoring decisions in a controlled and objective manner is one of them. In addition, proactive identification of supply challenges or non-compliance with supply usage can save thousands or even millions of dollars. The mobile capability of IRT systems will enable even further uses, making the technology work better within a site or patient workflow than any other technology available.

There are few vendors that understand the challenges of clinical trials and the opportunity IRT has to enable these trials to run effectively. As the go-to provider for complex studies that have emerged flawlessly from the FDA’s first IRT audit, Almac has the experience, expertise, and integrity required to deliver the results necessary to bring your drug to the patients who need it.

To find out more about OVERSIGHT, click here.

6 Best Practices in IRT Implementation for Clinical Trials in APAC

In 2019, the Asia Pacific (APAC) region represented 20% of all registered trials & 22.5% of all active/ongoing trials. To keep up with this pace, APAC Study Managers, Investigators and Supply Chain Managers (who have, until today, managed manual record-keeping in clinical trials) need to automate. IRT presents an opportunity for pharmaceutical sponsors conducting clinical trials in the APAC region to significantly improve productivity and data integrity.

The following steps serve as a best-practice approach to implementing an IRT in the APAC region. When system development proceeds in this way, the resulting tool will suit the study, and development time and costs will be minimized.

  1. Assemble the Project Design Team. On the sponsor side, this group typically includes the Clinical Team, the Drug Supply Team, Biostatisticians, and Data Managers. The vendor would normally involve Developers, Testers and Quality Assurance Specialists, led by a Business Analyst. To ensure efficient and clear communication, a project leader should be designated to funnel information from the stakeholders to the vendor.
  2. Hold a workshop to introduce the Project Design Team to what an IRT system can do prior to kicking off the project. It is recommended to walk through the system capabilities and show team members a demo of a sample system. This ensures that all parties have the same understanding of what is possible before they embark on the challenge of determining specific needs.
  3. Gather the specifications for the IRT using a systematic process. Working through a User Requirements Specification (URS) sheet helps direct the process of defining the project scope and the particulars of what will be needed. To properly configure the system, the developers will need input on a host of study elements. An experienced development team can ensure that the recommended approach is compliant with all applicable regulatory mandates from various ministries and regulatory bodies.
  4. Develop the system, using templates for standard functionality and customizing only those elements that are unique to the study. The development time can be cut down significantly when standard functionality will suffice, and the system can be built using established templates.
  5. Perform User Acceptance Testing (UAT) of the system. This is usually a multi-step process, with the vendor performing an initial UAT, followed by a sponsor UAT. The sponsor is provided with a test plan containing specific test cases and instructions on how to execute the UAT.
  6. Launch the system. It is recommended that all site users should be invited to an investigator meeting, where they receive training appropriate to their role. Ideally, they should all be provided with a quick reference guide bearing step-by-step directions on accessing and using the system.

The ultimate performance and value of an IRT system developed and implemented for APAC clinical trials can be assured through rigorous quality checks at four stages in the start-up phase: when requirements are finalized, once the code is programmed, after testing is completed, and during the implementation process when the system is ready to go live. Companies operating in APAC can look forward to a great leap in efficiency by adopting a well-tested IRT solution.

The Burden of Regulatory Compliance

By Richard Wagner

While there are obvious pressing logistical and operational challenges, there is also a tremendous amount of data that needs to be collected and managed during the course of a clinical trial. Not only is this data needed for the outcome of the trial itself, but it is also necessary for managing site regulatory compliance.

In a recent survey1 by CenterWatch, the clinical trial research company found that while half of the respondents said their site was on schedule when it came to the maintenance of regulatory tasks prior to an audit or monitoring visit, 28 percent were almost a week behind and 14 percent were two weeks behind. The reason for the backlog is because data tracked on paper can often fall to the wayside as a trial is being conducted until someone has the downtime to enter it into the relevant clinical data systems. This causes sponsors and/or supply managers to lose valuable visibility into what is going on at that site. Paper records begin to accumulate, and sites are soon faced with trying to find a place to store them along with the supplies.

At the end of the study, all of this information in paper records has to somehow come together into a complete chain of custody records that regulators will need access to as questions arise. Every adverse event that is recorded during the trial needs to be investigated, in order to determine which are significant. Sponsors have an ethical and moral responsibility to protect the safety of the patient. When patients experience an adverse event, there must be absolute certainty that the right patient has been given the correct drug.

The data management burden in clinical trials is compounded by the high turnaround rate of clinical research associates and monitors. Most clinical trials can run for numerous years. If paper records and/or unanswered questions begin to pile up as a revolving door of personnel is turning, you could potentially run into a situation where you cannot provide answers to vital questions regarding your study.

A promising solution

In line with the growing awareness of the need to better record “source” data electronically, electronic systems and technology can be powerful tools in improving the fragmented nature of the current chain of custody management processes. Any proposed technology solution must meet the needs of several stakeholders, in order to be successful. Notably, the following goals are paramount:

  • Reduce the supply management burden, both during the study and during study closeout, and reduce the possibility of a stock-out event at the site. The supply management team is also continually looking for ways to reduce the overall cost of producing, distributing, and tracking study medication.
  • Eliminate medication dispensing errors and retain patients on the trial. Clinical Operations are also interested in optimizing the trial monitor workflow and time-on-site, as well as incorporating any available historical data into site selection processes and use ongoing site performance metrics to support risk-based monitoring programs.
  • Preserve the flexibility necessary to accommodate unanticipated circumstances during patient care and to minimize the intrusiveness of the technology solution to delivering patient care. The site also wants an expedient and simple means for managing its inventory and meeting the accountability requirements of the study, while making the best use of potentially limited storage availability.

Introducing a system that can accomplish all of this and more could optimize the supply chain at every level. However, an ideal solution requires the support of both Clinical Operations and Supply Management. Both groups may have concerns about the implementation of a system such as this, and many are related to the potential disruption to established standard operating procedures. The key to designing and implementing a system that can be accepted by both teams and integrated into standard operating procedures more easily is to gain input from all stakeholders in the trial.

What stands in the way?

The pharmaceutical and healthcare industries are notoriously risk-averse. This is an understandable consequence of the critical nature of patient care and the potential risks associated with any errors. However, existing processes have, in many cases, evolved over a considerable period of time. Often, this may become more burdensome than desirable, while not contributing to any risk reduction or quality improvement. By implementing a more streamlined workflow with automated data entry and verification, costly and time-consuming processes, duplicate verifications and potential errors could all be reduced. Nonetheless, before you can begin the process of implementing this type of next-generation IRT system, you must first address any concerns of your stakeholders.

Find our more about OVERSIGHT here.

1 http://www.centerwatch.com/news-online/2015/04/01/ regulatory-compliance-an-increasing-burden-on-sites/
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