Player FM 앱으로 오프라인으로 전환하세요!
Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF
Manage episode 446539185 series 3472771
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.
_____________________________________________
Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0
Join our community: https://hubs.ly/Q027nggP0
Join us on Instagram: https://www.instagram.com/montrium/
Join us on Facebook: https://www.facebook.com/Montrium/
22 에피소드
Manage episode 446539185 series 3472771
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.
_____________________________________________
Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0
Join our community: https://hubs.ly/Q027nggP0
Join us on Instagram: https://www.instagram.com/montrium/
Join us on Facebook: https://www.facebook.com/Montrium/
22 에피소드
모든 에피소드
×1 Ask Paul - Our CEO Answers Your Most Pressing TMF Questions 39:48
1 Setting New Standards: What's in V4 of the TMF Reference Model? 57:37
1 Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF 49:45
1 More than an Archive - Moving to an Active TMF Management Model 42:58
1 Battle of the Binders: What's the Difference Between the TMF & the ISF? 55:41
1 Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews 52:56
1 Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study 33:20
1 Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged 56:30
1 TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023 51:59
1 Inspection readiness toolset - What tech do we need for the future? 35:56
1 Once Upon a TMF: Boosting Inspection Readiness with Storyboarding 54:25
플레이어 FM에 오신것을 환영합니다!
플레이어 FM은 웹에서 고품질 팟캐스트를 검색하여 지금 바로 즐길 수 있도록 합니다. 최고의 팟캐스트 앱이며 Android, iPhone 및 웹에서도 작동합니다. 장치 간 구독 동기화를 위해 가입하세요.