The much-awaited Veeva TMF Innovation Forum was held this year in Philadelphia—the forum aimed to promote lasting changes in clinical trial management related to the electronic Trial Master File.

The event was a remarkable opportunity for industry leaders to come together, share current thinking on critical matters, and further the development of clinical trials, with over 100 sponsor representatives in attendance.

At the Keynote session, Melissa Chiasson and Lisa Joseph from Takeda spoke about Takeda’s journey in transforming their business operating model (“Future Fit”). They also discussed how the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) have provided Takeda with greater transparency and oversight of their studies and greater flexibility in their approach to in-sourcing and outsourcing.

Next up was Supriya Shoroff from Eisai, who discussed the impact of ICH E6 (R3) on TMF operations.  This was a very informative session about how Eisai has taken a risk-based approach to TMF compliance and overall inspection readiness by looking at the entirety of the TMF management process and right-sizing the QC processes based on risk and what has already been performed earlier.

The next item on the agenda was a facilitated networking workshop called “Driving Solutions to Optimize TMF Management.” The groups were formed into smaller teams to brainstorm ideas on leveraging Artificial Intelligence, Machine Learning, and Robotic Process Automation for more effective and compliant TMF processes. Our conversations showed that people are interested in these solutions, but there is not yet a compelling business use case. Most of the discussion revolved around how to select sub-processes for automation instead of focusing on a large-scale transformation.

Lunchtime gave us a chance to chat with new acquaintances and catch up with old friends and co-workers. Laura Naranjo from Daiichi Sankyo’s fantastic presentation was a great way to start the afternoon session. She discussed how data could be used to simplify Essential Document Lists (EDLs) and streamline TMF completeness processes to create a “Revolutionary Year for TMF.”

Joanne Malia gave an incredibly engaging and direct talk about how Regeneron has improved the metrics of TMF with the help of its CRO partners. It was an exceptional session with step-by-step plans and advice on collaborating with CROs to obtain mutually useful metrics and overall improvements in quality.

Finally, Sara Kraft from AstraZeneca concluded the forum with a discussion on how the Innovation team of AstraZeneca identifies and implements innovations across the TMF process continuum to become a more data-driven organization.

Summary

Today, the clinical trial industry is increasingly recognizing the great importance of effectively and efficiently managing Trial Master File (TMF) documents. As clinical trials become more complex and demanding, streamlining document management processes is becoming increasingly vital. To address this need, the 2023 Veeva TMF Innovation forum was held to discuss digitalization in clinical trials and share innovative solutions for improving TMF document management. By using industry best practices, there is potential to significantly reduce the time needed to reconcile TMF documents, expedite the delivery of TMF documents for outsourced studies, and speed up document processing with AI to promote further clinical trial progress.

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