Time is running out: Managing clinical trials without eTMF is no longer viable

By Klaudia Markowski, Senior Business Consultant, NNIT

The backbone of every clinical trial is undergoing an inevitable digital revolution. Klaudia Markowski, Senior Business Consultant at NNIT, explains why the appropriate time to implement an electronic Trial Master File (eTMF) might be sooner than you think.

In the pursuit of more efficient and cost-effective clinical trials, IT decision-makers in the life sciences industry face a pivotal challenge: modernizing their Trial Master File (TMF) management to enhance efficiency, compliance, and oversight. The transition to an electronic Trial Master File (eTMF) system is not merely a technological upgrade; it is also a strategic imperative that can significantly influence the trajectory of clinical trials.

Embracing the eTMF imperative

Although the TMF is the backbone of clinical trial documentation, traditional TMF systems are often a patchwork of file-sharing platforms and spreadsheets. The rapidly increasing inadequacy of this approach is the main driver of the digital evolution towards eTMF.

The urgency stems from the evolving complexity and scale of clinical trials, which demands an innovative approach to TMF management.

– The right time to implement an eTMF is now. As clinical trials grow in number and complexity, so does the risk associated with manual TMF processes. The eTMF not only streamlines these complexities; it also catapults compliance and accessibility processes to new heights. It’s simply a non-negotiable in today's regulatory landscape, advises Klaudia Markowski, Senior Business Consultant at NNIT.

The cost of inaction

Life sciences organizations may hesitate to invest in an in-house eTMF due to perceived costs and efforts. However, Klaudia cautions against delay:

– Postponing eTMF adoption can accrue hidden costs — in managing complexities, rectifying compliance issues, and inefficient information retrieval. NNIT’s experience shows that early adoption can mitigate long-term expenses and operational bottlenecks.

Leveraging technology for compliance and oversight

While many pharma companies choose to outsource parts of their clinical research, it is always the sponsor’s responsibility to maintain TMF integrity throughout a trial. Without the ability to conduct full oversight, reliance on external Contract Research Organizations (CROs) can introduce risk.

– A sponsor-owned eTMF empowers sponsors with direct control, reducing dependencies and enhancing continuous inspection readiness. The ability to maintain real-time visibility and respond proactively to compliance concerns is just one strategic advantage provided by an eTMF system, asserts Klaudia and continues:

– The Covid-19 pandemic accelerated the shift to digital collaboration. Many organizations have adapted to online document storage and collaboration tools, laying the groundwork for more advanced eTMF systems. These systems offer more than storage — they enable workflow automation and provide actionable insights into TMF readiness and overall trial performance.

Strategic steps for TMF maturity

IT decision-makers in the life sciences sector must assess their current TMF infrastructure against future clinical trial demands.

Klaudia suggests asking these strategic questions to assess your need for an eTMF:

• Is your TMF infrastructure equipped to support a growing volume of complex studies?
• Are you confident in your TMF's inspection readiness?
• What is the Quality Control error rate for your TMF?
• How long does it take to document evidence of an activity in your TMF
• How much time and effort do you currently use on TMF management, including inspection readiness?

The answers to these questions will guide you in aligning your TMF strategy with organizational objectives.

A catalyst for clinical excellence

Regardless of the type of clinical trials your organization is engaged in, the introduction of an eTMF system is a transformative step forward with a significant impact on the quality of the research. As Klaudia puts it:

– An eTMF is not just a tool; it is also a catalyst for clinical excellence. Implementation of an eTMF system is a strategic decision that transcends technology, encompassing compliance and data integrity while future-proofing clinical trial operations.