Ramblings and Ruminations on the Latest Trial Master File Summit
eTMF was hot 3 years ago, it’s even hotter now – There was a palpable buzz throughout the TMF Summit this year – a feeling that as an industry we are ready to take the next step in our collective TMF evolution. This positivity and excitement was echoed throughout all the presentations. A lot of credit also goes to Scott Grossman and his team at ExL for cultivating this environment with their thought provoking agenda. The proof is in the pudding, 140 attendees made this the largest TMF Summit to date.
Inspection readiness remains a challenge but also presents an opportunity – The MHRA update of critical findings was continually referenced throughout the presentations. Those first generation eTMF models have had incremental impact on productivity and compliance, but the industry is now looking to move toward a more integrated, collaborative eTMF operating model. We are at an inflection point where technology vendors, consultants, life sciences organizations (IT and business groups) and regulators expect more. As a result, I foresee some positive disruption in the near-term…
The definition of an eTMF application is evolving – There’s a clear shift from passive eTMF archives (flat file shares) to active eTMF applications with advanced business process management functionality. The eTMF can be both a tactical and strategic asset to an organization, something that teams use on a daily basis not only to manage content, but to manage their clinical processes. This belief is gaining traction and the eTMF application is being viewed as a critical component of clinical development operations.
Change is tough but inevitable – Industry sees the value of these next generation eTMF technologies but transforming the underlying paper processes to electronic processes is tough. Both, organizations embarking on their first eTMF model and those that have implemented a first generation technology, are looking to optimize their processes by leveraging technology. We’re (the TMF community – vendors, sponsors, CROs, consultants) changing not only the way we manage the TMF but how we run clinical trials. A tough but impactful change.
Jason Methia is Director, Vault eTMF Strategy at Veeva.