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Ask Paul - Our CEO Answers Your Most Pressing TMF Questions
Manage episode 455122242 series 3472771
Get ready for an engaging and interactive episode of The State of TMF! Montrium’s CEO, Paul Fenton-Carter, takes center stage for a no-holds-barred AMA (Ask Me Anything) session.
Paul will be answering questions submitted by the audience, diving into key topics shaping the TMF industry today, from current challenges in clinical documentation to the future of TMF management in a rapidly evolving landscape. Whether you’re curious about his vision for the industry, best practices for TMF management, or insights into upcoming trends, this is your chance to hear directly from one of the leading voices in the field.
CHAPTERS:
00:00 Topic Teaser w/ Paul Fenton-Carter
00:28 Speaker and topic intros
01:36 Exploring how the role of the TMF manager is evolving
06:05 Examining the industry's progress in adopting risk-based TMF management
12:40 Insights on the rapid incorporation of AI and its impact on TMF management
18:02 Discussing the challenges of accurately measuring completeness
24:25 Understanding the importance of ICH M11 and its impact on TMF
31:00 Key considerations around ICH E6(R3) and its implications for TMF
37:39 Addressing common misconceptions about TMF
38:40 Wrap up
39:20 Outro
_______________________________________________
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/
23 פרקים
Manage episode 455122242 series 3472771
Get ready for an engaging and interactive episode of The State of TMF! Montrium’s CEO, Paul Fenton-Carter, takes center stage for a no-holds-barred AMA (Ask Me Anything) session.
Paul will be answering questions submitted by the audience, diving into key topics shaping the TMF industry today, from current challenges in clinical documentation to the future of TMF management in a rapidly evolving landscape. Whether you’re curious about his vision for the industry, best practices for TMF management, or insights into upcoming trends, this is your chance to hear directly from one of the leading voices in the field.
CHAPTERS:
00:00 Topic Teaser w/ Paul Fenton-Carter
00:28 Speaker and topic intros
01:36 Exploring how the role of the TMF manager is evolving
06:05 Examining the industry's progress in adopting risk-based TMF management
12:40 Insights on the rapid incorporation of AI and its impact on TMF management
18:02 Discussing the challenges of accurately measuring completeness
24:25 Understanding the importance of ICH M11 and its impact on TMF
31:00 Key considerations around ICH E6(R3) and its implications for TMF
37:39 Addressing common misconceptions about TMF
38:40 Wrap up
39:20 Outro
_______________________________________________
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/
23 פרקים
כל הפרקים
×1 Bridging Files - A look at the ISF Reference Model 51:15
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 Crafting a TMF Training Program for your Team 53:12
1 Trackers & Logs in the TMF: Where to file them? 54:38
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 Is eTMF tech working for small companies? 45:59
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