The State of TMF
By Montrium
Categories: Science, Life Sciences, Education, Business
Welcome to the State of TMF podcast. 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'll understand everything it takes to create a world-class TMF program. As subscribers, you'll learn how to take your TMF process and strategy to the next level. Through interviews, AMAs, and invite-only events, we give you a sneak peek into the data-backed insights we're executing for TMF teams across the globe.
28 episodes indexed on PodSearch.
Recent episodes
- TMF Standard Model V1: From Reference Model to Digital Standard
Two years in development, the TMF Standard Model V1 draft opens for community review on October 19. What changes for your team? Paul Carter and Christina Mantzioros explain what V1 is and how it differs from the TMF Reference Model. You'll hear why V1 is a digital, evidence-based standard built…
- Documents without a plot: why your inspector can't follow your TMF
A complete TMF doesn't always mean a clear one. In this episode, we dig into one of the most common and underappreciated inspection risks: the TMF that technically has everything, but still can't tell you what actually happened. We break down the two root causes that derail TMF narratives: missing…
- The CRO TMF Handoff: The solution to hidden compliance gaps in CRO to sponsor TMF transfers
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…
- Quality by Design: Bridging the TMF - Quality Gap in Your Study
In this episode, our experts will be diving into QbD and how this proactive approach is shaping clinical trial management. From ensuring compliance to improving overall trial efficiency, we’ll explore why embedding quality from the start is critical for clinical success.Joining us for this…
- ICH E6(R3): The Birth of the (Digital) Record
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…
- Bridging Files - A look at the ISF Reference Model
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…
- Ask Paul - Our CEO Answers Your Most Pressing TMF Questions
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…
- Setting New Standards: What's in V4 of the TMF Reference Model?
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…
- Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF
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…
- More than an Archive - Moving to an Active TMF Management Model
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…
- Battle of the Binders: What's the Difference Between the TMF & the ISF?
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…
- Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews
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 episode 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…
- Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study
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…
- Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged
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…
- Crafting a TMF Training Program for your Team
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…
- Risk-Based TMF Management 101
Risk-based TMF management is set to be all the rage in 2024, and we want to help you hit the ground running. On the latest episode of The State of TMF, our experts shared their innovative and unique approach to risk-based TMF. They were also be joined by InSeption Group's EVP of QA & Compliance…
- Trackers & Logs in the TMF: Where to file them?
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…
- TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023
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.Subscribe to The State of TMF Live Events…
- Inspection readiness toolset - What tech do we need for the future?
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…
- Is eTMF tech working for small companies?
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…
- Once Upon a TMF: Boosting Inspection Readiness with Storyboarding
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…
- Lights, Camera, Inspection: Performing Oscar-Worthy Mock Inspections
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. Subscribe to The State of TMF Live Events ->…
- The New Inspection Frontier - Navigating Remote & Hybrid GCP Inspections
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…
- Set Yourself up for Inspection Success: Leveraging TMF Health Checks & Oversight
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.Sound interesting? Then…
- Mergers, Acquisitions & Shelved Compounds: Dealing with TMFs with Steph Viscomi & Dawn Niccum
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…
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