3 Tips For Selecting Your eTMF Platform

By Suzanne Turner, ICE Consulting

In recent years, a noticeable trend in the clinical research landscape is the increasing number of sponsors opting to bring their TMFs in-house. This strategic move necessitates the challenging task of selecting the most suitable eTMF platform. It's important to acknowledge that a one-size-fits-all option isn’t a reality. Each eTMF platform presents its own set of advantages and drawbacks, often subjective in nature. Ultimately, the decision-making process hinges on the unique requirements of the company.

First, let’s clear one thing up: the difference between a Trial Master File (TMF) and an Investigator Site File (ISF). The TMF encompasses all study records collected by the sponsor, whether electronic, paper, or a mix. This includes all countries and sites in one location. It's accessed by both sponsors and vendors. Conversely, the ISF is maintained by investigators and contains site-specific documentation only. Despite being separate, certain ISF documents are duplicated and collected during monitoring visits to ensure sponsor oversight, ultimately ending up in the TMF.

Now, back to the TMF.

Undoubtedly, cost emerges as a pivotal consideration in this decision-making process. However, basing the decision solely on cost is a recipe for potential regrets down the line. Choosing the right platform is a substantial commitment for any company, and once the decision is made, it becomes integral to the organization's workflow for years to come. Therefore, it's imperative to delve deeper into other critical factors that warrant consideration alongside cost when evaluating eTMF platforms.

End User Focus

One aspect that is often overlooked in the decision-making process is the end user experience. It's a critical factor that deserves significant attention. After all, the trial and TMF teams are the ones who will be actively engaging with the platform day in and day out — uploading records, conducting quality checks, and retrieving records. Neglecting their needs can have a substantial impact on the overall health of the TMF.

I've witnessed firsthand the repercussions of users’ struggles with system navigation or record uploads. Such challenges can lead to procrastination among users, eventually culminating in compliance issues. Compliance issues can incur significant costs if remediation is required. Cleaning up a TMF is both expensive and time consuming, potentially causing delays in NDA submission. I worked with a client who had the FDA walk out of their inspection due to difficulties locating records because of poor naming conventions. That frustration cost them a lot of time and money.

Consequently, it's imperative for sponsors to prioritize the user-friendliness of the system. This includes features such as easy navigation, simple workflow processes, helpful search functions, and built-in reporting capabilities. In fact, seeking input from potential end users during the decision-making process can provide invaluable insights.

• Pre-Evaluation: Start by gathering feedback from potential end users to understand their needs, pain points, and wish list items. Even if your company doesn't currently have a TMF platform, users likely have valuable insights from working with vendor systems. Consider conducting meetings or sending out email surveys to ensure anonymity and encourage participation.
• During Evaluation: Once you've narrowed down your options to a couple of platforms, involve end users in the evaluation process. Offer demonstrations where they can navigate the systems and ask questions. This hands-on experience can lead to "aha" moments and reveal any potential gaps or concerns they may have.
• Pre-Implementation: As you finalize your platform choice, engage end users in the User Acceptance Testing (UAT) phase. This allows them to identify any issues or gaps before the system goes live. Additionally, involving users early on can turn them into advocates for the new system, spreading excitement and helping to support their peers during the transition.

Process Alignment

Another crucial aspect to weigh is whether the system aligns with the sponsor's specific needs. This encompasses essential process requirements like the capability for a two-step QC on records and access to audit trails. However, it extends beyond the basics — are the system functionalities conducive to compliance with existing SOPs?

For sponsors with established processes, it's essential to conduct a thorough evaluation, outlining necessary actions including both mandatory and desirable system functionalities. These might encompass additional features such as the ability to log quality issues or integration with their CTMS system. It's also prudent to contemplate future possibilities. Even if certain functionalities may not be feasible at present, does the system offer scalability for future expansion when resources allow?

Addressing the absence of a TMF process within a sponsor organization can often pose a “chicken or egg” dilemma. Which approach is preferable: establishing a process and then selecting a platform to complement it, or choosing a platform and subsequently crafting a process to fit? This question sparks debates, as each option presents its own set of advantages and drawbacks.

Drawing from my experience, I advocate for initiating the process first. While both approaches have merits, it's been my observation that starting with the process minimizes frustration in the long run. Attempting to construct a process post-platform selection, only to encounter the system's limitations, can prove considerably more challenging than entering the scenario with a clear understanding of necessary adjustments and modifications.

Inspection Considerations

At the 2023 CDISC TMF Interchange, a panel discussion on current inspection trends shed light on a notable shift — remote inspections are increasingly common. This shift offers inspectors greater flexibility, blurring the traditional boundaries of inspection timelines and potentially extending their duration beyond initial plans.

These developments underscore several considerations when evaluating a platform. First, the platform must accommodate remote inspections, necessitating the availability of an auditor or inspection role that can be provided for proper access. This user role allows the inspector “read only” access to the eTMF. While most reputable platforms offer this functionality, it's prudent to verify it beforehand and confirm what functions are included (e.g., do they see all documents or only final documents, can they only view documents or also download them, etc.).

Additionally, sponsors should reflect on whether they'd feel confident presenting the platform to an inspector. Beyond system validation, which is undoubtedly crucial, consideration should be given to the platform's user-friendliness as mentioned above. The last thing a sponsor desires during an inspection is a cumbersome platform that frustrates inspectors as they review records.

Closing Thoughts

Implementing an eTMF represents a significant investment for any company. It's crucial to recognize that the TMF stands as a culmination of the team's relentless efforts over years, serving as the cornerstone presented to the FDA. Therefore, it's paramount that the chosen system seamlessly complements this process, fulfilling the sponsor's specific needs and expectations.

One invaluable piece of advice I always emphasize is the necessity for sponsors, especially those new to working with eTMFs, to seek guidance from a seasoned TMF subject matter expert (SME). These experts, having dedicated years to TMF management, possess a wealth of experience across various platforms. They can not only assess if a platform aligns with the sponsor's requirements but also highlight any known limitations or challenges. This proactive approach empowers sponsors to make well-informed decisions, preventing potential process disruptions or preparing for the need for workarounds.

About The Author:

Suzanne Turner, founder of ICE Consulting, LLC, brings over 11 years of TMF management experience across CRO, sponsor, and consulting sectors, and is a CDISC TMF volunteer. Establishing ICE Consulting in 2023 allowed Suzanne to focus on direct collaboration with sponsors, particularly smaller companies, tailoring solutions to their unique needs.

Her expertise lies in strategic and risk-based considerations for TMF process creation, implementation, and disaster management. She has a passion for TMF management, process development, inspection readiness, engagement, and compliance. Her skill set extends to creating and providing training, functional management, team leadership, and TMF vendor oversight.

Connect with Suzanne on LinkedIn or visit her website to learn more.