The State of TMF

This is no April Fools joke...The State of TMF podcast is back for a new season and we're jumping into a hot topic.The end-of-study TMF transfer shouldn't be a black box. But for too many sponsors it is, until they're staring down a list of inspection findings.In this episode, Paul Carter and Christina Mantzioros share tried and tested ways to identify TMF problems before your CRO sends the final package, and how AI-powered risk models can help you verify completeness and quality without manually checking thousands of documents.CHAPTERS:0:00 Introduction1:00 Season 4 Premiere & Episode Overview2:00 Sponsor Oversight Challenges When CROs Manage the TMF7:00 When the CRO Hands the TMF Back: What to Expect10:00 Archiving the TMF: Where to Store It and What's in Scope13:00 TMF Plans, Data Transfer Agreements, and Authoritative Source17:00 Evaluating TMF Quality at Handover: Evidence of Oversight20:00 Risk-Based Oversight and ICH E6(R3) Requirements23:00 Q&A: Contract Timing, Cost Pressure, and CRO Access27:00 What Regulators Expect: Proactive vs. Reactive Oversight30:00 Q&A: Transferring Documents and Audit Trails35:00 How AI Can Improve TMF Oversight41:00 Q&A: Using AI Securely and Deterministically46:00 Closing & Season 4 Episode 2 Preview

In this episode, our experts will be diving into ICH E6(R3) and the shift from documents to truly digital, regulatory-compliant records. Clinical trial management is evolving, and this discussion will explore what that means for the future.Joining us for this conversation is our President & CEO, Paul Fenton-Carter, , alongside Karen Roy from Epista and Joanne Malia from Regeneron. Together, they’ll discuss what we know about ICH E6(R3) now, what's to come in the future, and how this shift will impact the industry._____________________________________________CHAPTERS: 00:00 Hot Take w/ Joanne Malia00:30 Welcome and topic intro01:03 Guest intros (Joanne Malia and Karen Roy)03:53 Important changes to the final version of ICH E6 R306:39 Areas where risk-based approach is useful08:05 ICH M11 & digital protocol10:21 Names changes, terminology & guidance documents13:26 Question from the audience (Nomenclature)15:20 ICH and the TMF Reference Model17:25 Criteria /decisionguide20:14 Timeline for TMF Ref Model V422:45 Essential records table & Records that go across studies27:05 Questions from the audience 41:33 Wrap up44:41 Outro_____________________________________________Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Joanne Malia: https://www.linkedin.com/in/jsmalia2008/Karen Roy: https://www.linkedin.com/in/karenjroy/ _____________________________________________TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-modelSubscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

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-Carter00:28 Speaker and topic intros01:36 Exploring how the role of the TMF manager is evolving06:05 Examining the industry's progress in adopting risk-based TMF management12:40 Insights on the rapid incorporation of AI and its impact on TMF management18:02 Discussing the challenges of accurately measuring completeness24:25 Understanding the importance of ICH M11 and its impact on TMF31:00 Key considerations around ICH E6(R3) and its implications for TMF37:39 Addressing common misconceptions about TMF38:40 Wrap up39:20 Outro_______________________________________________Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

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.CHAPTERS00:00 Topic Teaser00:50 Speaker intros03:36 Topic intro04:30 The Heart of Digital TMF and the new standard ICH M1117:20 How will the new standards affect Sponsors and CROs?19:41 Functions impacted outside of TMF with the new standard25:00 Impact on the vendor ecosystem29:24 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 processes42:30 Hurdles Vendors and Sponsors might face with the implementation of M1145:45 How to prepare for the changes48:25 Wrap up49:15 Outro_____________________________________________Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

Distinguishing between the ISF and the TMF is an all-too-frequent source of confusion in clinical documentation. Are they the same? Are they different? The answer to both of those questions is yes.Join special guests Aryn Knight and Matt Lowery as they get into the nitty gritty of the great ISF-TMF debate. We'll be covering which contents are specific to the ISF vs which are specific to the TMF, who is responsible for each, their different regulatory requirements, and inspection readiness for both.---------------------------------------------------------Aryn Knight on LinkedIn: Matt Lowery on LinkedIn: Register for for episode #9 @TMF Week 2024Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

It's important to have standards—especially when it comes to the TMF index. Aligning your TMF index to the CDISC TMF Reference Model makes it easy for organizations to speak the same language, helps you breeze through M&As, and streamlines system migrations.In this episode of the State of TMF, our host Oliver Pearce will be joined by guest Anne Ackley-Fifer from Daelight Solutions. They'll discuss how you can build a flexible and adaptive TMF index for any study, without straying from the standard-----------------------------------------------Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/Daelight Solutions: https://daelightsolutions.com/

We kicked off 2024 with our most popular State of TMF episode yet! Loads of you turned up to last week to learn more about TMF training—and how to do it right.Not only did our hosts share their foolproof 5-step formula for crafting an effective TMF training program for your team, but they also got real about some of the training struggles they've faced throughout their careers.If you or your team ever struggle to understand roles, responsibilities, TMF maturity levels, and any of the other complexities that come with this line of work—then this episode is for you!-----------------------------------------------Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/Join us on Facebook: https -> https://www.facebook.com/Montrium/

Trackers and logs are a notorious source of confusion in the TMF. But fear not, because our experts joined forces to discuss exactly where you should be filing trackers and logs in your TMF.They also shared a real (scary) story about what happens when an inspector asks to see a log that wasn't maintained 😱 and how you can avoid this happening to you.How are you enjoying The State of TMF series? We want to know what you love, what you don't love, and your suggestions for making it the most valuable podcast possible. You'll also get the chance to leave your own burning question(s) on the hot topic of risk-based TMF so we'll be sure to cover them in the next episode. You can fill out the super quick, 2-minute touchpoint by clicking this link--------------------------------------------------------------------------Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/Join us on Facebook: https -> https://www.facebook.com/Montrium/

On the final episode of Season 1 of The State of TMF, our panel of experts did a deep dive into the tools you need to be inspection-ready—today AND tomorrow. Our host, Oliver Pearce, was joined by Paul Fenton and Donatella Ballerini from Montrium, and Jamie Toth from BeiGene.Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

In this insightful session, Oliver Pearce and Donatella Ballerini reveal how storyboarding can become your secret weapon in boosting confidence when it comes to the inspection readiness of your TMF.  Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

In this riveting episode, our panel of experts took a deep dive into the evolving world of remote and hybrid inspections, and offered their best tips for how to be better prepared for this new reality. Featuring Paul Fenton of Montrium, Joanne Malia of Regeneron, and David Ives of Daelight SolutionsSubscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

In this episode, we'll be tackling the complex situations that can quickly turn into a TMF manager's nightmare: mergers, acquisitions, and shelved compounds.Your favourite host, Oliver Pearce, will be joined by expert guests Steph Viscomi and Dawn Niccum to discuss how to navigate these processes without losing too much sleep.Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0