The State of TMF Live Podcast

Recorded on Wednesday, October 9th @ 11am ET

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. Join Paul Fenton-Carter of Montrium and Nick Hargaden of Moderna as they explore the future of the TMF as it transitions into a fully digital landscape.

They'll discuss the current gaps that prevent TMF from being truly digital, examine key initiatives like ICH M11 and Digital Data Flow, and highlight the benefits of a data-driven approach. You'll leave understanding how to unlock the vast goldmine of information stored within the eTMF.

Recorded on Wednesday, November 14th @ 11am ET. 

A lot has changed since Version 3 of the TMF Reference Model was released in 2015. The growing adoption of digital technologies, combined with increasing amounts of data collection, have made for a vastly different landscape—one that requires different approaches to TMF management. Thus, enter: Version 4.

In this expert-led breakdown of V4, Montrium's President & CEO (and new co-chair of the TMF Reference Model) Paul Fenton-Carter is joined by the model's founder and former chair, Karen Roy. Together, they'll explore the changes  you'll see in V4, as well as the impact these updates will have on clinical documentation management.

Recorded on Wednesday, Dec 4th @ 11am ET. 

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.

Recorded on Wednesday, Jan 15th @ 11am ET. 

In this episode of The State of TMF, we dive into the latest developments surrounding the ISF Reference Model, a pivotal initiative aimed at standardizing Investigator Site Files across the clinical research industry.

Host Paul Fenton-Carter of Montrium is joined by Jamie Toth of BeiGene and Matt Lowery of The Pathways Group, two key contributors deeply involved in shaping this groundbreaking project. Together, they explore the progress made so far, the challenges faced, and what the future holds for the ISF Reference Model. From aligning global teams to addressing practical implementation hurdles, this episode offers valuable insights for anyone invested in improving clinical trial documentation practices.

Recorded on Wednesday, Feb 12th @ 11am ET. 

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.

Live on Wednesday, March 12th @ 11am ET. 

Episode Information Coming Soon

Live on Wednesday, April @ 11am ET. 

Episode Information Coming Soon

Recorded on Wednesday, October 25th @ 11am ET

Our experts sat down to discuss the unexpected findings from our first-ever industry report and graced us with some non-stop fire insights about the TMF world of today, and tomorrow. It was the perfect way to kick off the second season of The State of TMF.

Recorded on Wednesday, November 22nd @ 11am ET

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.

Recorded on Wednesday, December 13th @ 11am ET

Our experts sat down and shared their innovative approach to risk-based TMF management.

They were also joined by InSeption Group's EVP of QA & Compliance, Dawn Niccum, to discuss the past, present and what all TMF'ers need to know about the imminent future of risk-based TMF. 

Recorded on Wednesday, January 10th @ 11am ET

Training is a regulatory requirement, but TMF isn't exactly something you learn in college.

Join us as we share how to craft effective and engaging TMF training programs, from mapping team roles and assessing maturity, to monitoring progress and evaluating performance. Plus, we'll throw in some of our best insider tips for augmenting your training program!

Recorded on Wednesday, February 14th @ 11am ET

If the TMF is the cornerstone of a clinical trial, then why do so many TMFers find themselves having to convince others of its importance?

The answer: culture. In this episode, we crack the TMF culture code and explain how you can get stakeholder buy-in, keep non-TMFers engaged, and ensure that everyone is doing their part. Our experts will discuss tips for training, ways to gamify TMF management, the process of creating TMF champions, and more!

Recorded on Wednesday, March 13th @ 11am ET

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.

Recorded on Wednesday, April 10th @ 11am ET

Audit trail reviews may be a hot topic in the world of TMF right now, but that doesn't mean people know how to do them the right way.

In this epsiode of The State of TMF, our experts will explain everything you need to know about audit trail reviews. We'll be going over the basics of audit trail reviews, the "why" and "how" of routine ATRs, which high-risk data points you should be reviewing, and more!

Recorded on Wednesday, May 8th @ 11am ET

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.

Recorded on Wednesday, June 12th @ 11am ET

Managing your TMF program effectively with outdated or inefficient processes can feel overwhelming, especially with limited resources and an evolving regulatory environment. Today, teams are transitioning away from passive TMF models that prioritize an archivist mindset towards a more modern and agile approach to TMF focused on managing and compiling the TMF in an active manner.

In this session, Donatella Ballerini and Oliver Pearce of Montrium will guide you through the essential components of active TMF management. They will introduce Montrium's TMF Maturity Model, providing a structured approach to evaluate and advance your TMF processes. You'll learn how to leverage technology for real-time oversight and ensure your TMF team maintains an agile TMF mindset.

Recorded on Wednesday, August 23rd @11am ET

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.

Recorded on Wednesday, August 9th @11am ET

In this "food for thought" episode, our panel of experts explored the challenges presented by the eTMF technology currently available in the life sciences industry. Paul, Christina, and Oliver offered practical and actionable recommendations that small companies can take when implementing an eTMF system.

Recorded on Wednesday, July 26th @11am ET

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.

Recorded on Wednesday, July 12th @11am ET

In this episode, experts Oliver Pearce and Christina Mantzioros turn the spotlight on the undeniable benefits of mock inspections, with actionable insights to put them into play and bolster your inspection readiness success from here on out.

Recorded on Wednesday, June 28th @11amET

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 Solutions

Recorded on Wednesday, June 14th @11amET

The State of TMF is BACK, and in this episode, our experts will be discussing how to set yourself up for inspection success with TMF health checks and oversight. You'll come away with practical tips and actionable insights to help you maximize your inspection readiness.

Recorded on Wednesday, April 26th @11amET

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.

Recorded on Wednesday, April 12th @11amET

Metrics, metrics, metrics. Despite metrics being one of the most popular topics in the world of TMF, there's still a fair bit of confusion about what they entail and how to leverage them correctly. We'll be tackling this confusion head-on and addressing some of the most prominent knowledge gaps when it comes to metrics in the third episode of The State of TMF.

Recorded on Wednesday, March 29th @11amET

TMF correspondence can be tricky. Have you ever found yourself asking what to keep, what not to keep, and where to keep it? Well, you're not alone. These are all perfectly normal questions that come up often when managing a TMF. In this episode, you'll learn how to properly manage TMF correspondence and how to put in place a process that your team can rely on. Join us for episode #2 of the State of TMF podcast.

Recorded on Wednesday, March 15th @ 11amET

To file or note to file? That is the question. And it's one that continues to plague TMF professionals of all levels of experience. In this episode, we'll be discussing the dos and don'ts of writing note to files and how to develop a process that builds confidence in an inspection instead of undermining it. Join us for our very first episode of the State of TMF podcast.