The State of TMF Live Podcast

Welcome to the State of TMF podcast. The #1 TMF podcast on the planet!

Join us each episode and you'll learn how to take your TMF process and strategy to the next level. From providing insights on how to improve inspection readiness to identifying and scaling optimization programs that work, to training your team to operate at scale - you will understand what is takes to create a world class TMF program. Through interviews, AMA's, and invite-only events, we give you a sneak peek into the data-backed insights we are executing for TMF teams across the globe.


SOTMF_Season 2_LP header 3

Looking to join the live event? Register now for State of TMF Live

Season 2

Check out what's in store this season!
The State of TMF: Season 2 Episode 1 - TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023

Episode 1 - TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023

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.

The State of TMF: Season 2 Episode 2 - Trackers & Logs in the TMF: Where to file them?

Episode 2 - Trackers & Logs in the TMF: Where to file them?

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.

The State of TMF: Season 2 Episode 3 - Risk-based TMF Management 101

Episode 3 - Risk-based TMF Management 101

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. 


The State of TMF: Season 2 Episode 4 - Building an Internal TMF Training Program

Episode 4 - Putting the "Fun" in TMF Fundamentals: Building an Internal TMF Training Program

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!

The State of TMF: Season 2 Episode 5 - Building Champions & Getting Non-TMF’ers engaged

Episode 5 - Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged

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!

State of TMF - S2 E3

Episode 6 - Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study

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.


State of TMF - S2 E7

Episode 7 - Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews

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!

State of TMF - Season 2 Episode 8

Episode 8 - Battle of the Binders: What's the Difference Between the TMF & the ISF?

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.


Episode 9 - Details coming soon

Wednesday, June 12th @ 11am ET

Catch up on Season 1

The State of TMF_Episode graphic_LP_10 (1)

Ep#10 - Inspection readiness toolset - What tech do we need for the future?

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.

The State of TMF_Episode 9

Ep#9 - Is eTMF tech working for small companies?

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.

SOTMF_Episode_for Social_08

Ep#8 - Once Upon a TMF: Boosting Inspection Readiness with Storyboarding

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.

The State of TMF_Episode graphic_LP_07-1

Ep#7 - Lights, Camera, Inspection: Performing Oscar-Worthy Mock Inspections

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.

The State of TMF_Episode graphic_LP_06-1

EP#6: The New Inspection Frontier - Navigating Remote & Hybrid GCP Inspections

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

The State of TMF_Episode graphic_LP_05-1

EP#5: Set yourself up for Inspection Success - Leveraging TMF Health Checks & Oversight

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.

The State of TMF - Episode 4 Graphic

EP#4: Mergers, Acquisitions & Shelved Compounds: Dealing with TMFs

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.

The State of TMF_Epsiode graphic_LP_03-1

EP#3: Numbers don't lie - building a TMF Metrics Program from the Ground up

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.

The State of TMF Episode 2

EP#2: You've got mail - Building an intuitive process for TMF Correspondence

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.

The State of TMF Episode 1

EP#1: Confessions of an Ex-TMF Manager - Breaking Bad Habits with Note to Files

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.

Find us on your favourite podcast platform


Register for the live events

Join us once a month, LIVE!

The State of TMF is a bi-weekly live event dedicated to providing you with practical knowledge that you can take away and implement the next day. Register for the live event to ask questions and interact with our hosts.

Join our growing community 1000+ TMF professionals

Be a part of the fastest growing TMF community group in the industry. Share ideas, ask questions and join the conversation

Join community
State of TMF Community

Your Hosts

The State of TMF is hosted by industry veterans and experienced TMF'ers from Montrium

  • Oliver Pearce

    Oliver Pearce

    Director of Growth Marketing

    A 10 year TMF veteran with extensive experience in system implementation and validation, Oliver brings his technology expertise to The State of TMF.

  • Donatella Ballerini

    Donatella Ballerini

    Head of eTMF Services

    Our resident Queen of TMF, Donatella with almost 20 years experience in leading trial master file and compliance teams at a host of leading European sponsors

  • Paul Fenton

    Paul Fenton

    President & CEO

    The TMF community's go-to technology expert and Montrium's fearless leader. Paul has over 30 years experience in developing technology to support clinical trials and sits on the leadership team on the CDISC TMF Reference Model.

Frequently asked questions

Is each session recorded?

Yes. All sessions are recorded and made available on YouTube and all major podcast platforms.

Can I get access to the slide deck?

Of course. Slides from each of our presentations are available exclusively within the State of TMF LinkedIn Community Group. You can find it here.

How can I attend the live events?

Save your seat at one of the live shows by completing the short form above. You'll receive details on how to join each event via email the week of the event.

Do I need to register for every event individually?

Nope. Once you've registered for State of TMF Live, you're signed up for every session we hold. If you've saved your seat already, look out for an email the week of the event with details on how to join.

Can I be a guest speaker on The State of TMF Live?

Of course, we welcome speaker suggestions. If you're interested in speaking or want to recommend a guest please email marketing@montrium.com

What is the State of TMF Community group?

To add value to our audience, we've set up a private community group on LinkedIn. In the group we'll share exclusive content, engage in discussion and Q&A. You can find it here.