Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF

The State of TMF

From paper to pixels, the TMF has come a long way in its digital transformation—and so have the ways in which we manage it.

In this episode, Paul Fenton of Montrium and Nick Hargaden of Moderna will explore the future of the TMF as it transitions into a fully digital landscape.

We'll discuss the current gaps that prevent TMF from being truly digital and examine key industry initiatives, including ICH M11 and Digital Data Flow from Transcelerate, to understand their impact on eTMF systems. We'll also highlight the benefits of a data-driven approach in enhancing quality, timeliness, and compliance, while revealing how it can unlock the vast goldmine of information stored within the eTMF to improve oversight and streamline clinical process management.

CHAPTERS

00:00 Topic Teaser

00:50 Speaker intros

03:36 Topic intro

04:30 The Heart of Digital TMF and the new standard ICH M11

17:20 How will the new standards affect Sponsors and CROs?

19:41 Functions impacted outside of TMF with the new standard

25:00 Impact on the vendor ecosystem

29:24 The regulatory impact

34:50 How can Sponsor adapt to the new standard?

37:24 Will Regulatory bodies be lenient with the changes?

40:05 Regulatory processes

42:30 Hurdles Vendors and Sponsors might face with the implementation of M11

45:45 How to prepare for the changes

48:25 Wrap up

49:15 Outro

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