Shows
The State of TMFDocuments without a plot: why your inspector can't follow your TMFA 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 context (the "why" behind decisions and deviations) and missing connections (how documents relate and sequence into a coherent study story). We'll also look at how inspectors actually read a TMF, and what they're really looking for when they try to follow the thread.
2026-05-0646 min
The State of TMFThe CRO TMF Handoff: The solution to hidden compliance gaps in CRO to sponsor TMF transfersThis 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:
2026-04-0146 min
The State of TMFQuality by Design: Bridging the TMF - Quality Gap in Your StudyIn 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 discussion is our President & CEO, Paul Fenton-Carter, and our Head of eTMF Services, Donatella Ballerini. Together, they’ll break down how QbD principles can enhance TMF quality, reduce risks, and future-proof trial documentation.-------------------------------------CHAPTERS:00:00 Hot Take w/ Paul Fenton-Carter00:40 Speaker Intros 01...
2025-04-2352 min
The State of TMFICH E6(R3): The Birth of the (Digital) RecordIn 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 Malia...
2025-02-1945 min
The State of TMFBridging Files - A look at the ISF Reference ModelHost 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.CHAPTERS:00:00 Hot Take w/ Matt Lowery00:35 Guest intros (Jamie Toth and Matt Lowery)01:55 Topic Intro & History of ISF
2025-01-2251 min
The State of TMFAsk Paul - Our CEO Answers Your Most Pressing TMF QuestionsGet 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 t...
2024-12-1139 min
The State of TMFSetting 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: Version 4 of the TMF Reference Model.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 new features and changes you'll be seeing in V4, as well as the im...
2024-11-2057 min
The State of TMFUnlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMFFrom 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 en...
2024-10-2349 min
SCORRCASTGrowth | Disrupt or Be Disrupted: Bold Moves in Life Science MarketingExplore bold moves in life science marketing in this episode of The SCORRcast with Oliver Pearce from Montrium. Learn how to disrupt or be disrupted in the ever-evolving life science industry. Discover innovative strategies, expert insights, and actionable advice to stay ahead of the competition and drive growth. Whether you're a seasoned marketer or new to the field, this episode provides valuable knowledge to enhance your marketing efforts.
2024-08-0748 min
The State of TMFMore than an Archive - Moving to an Active TMF Management ModelManaging 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...
2024-06-2542 min
The State of TMFBattle 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 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...
2024-05-1455 min
The State of TMFLeaving No Stone Unturned: The TMFer’s Guide to Audit Trail ReviewsAudit 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 reviews, the "why" and "how" of routine ATRs, which high-risk data points you should be reviewing, and more!-----------------------------------------------Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0...
2024-04-1652 min
The State of TMFFinding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any StudyIt'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 Ev...
2024-03-1933 min
The State of TMFCracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engagedIf 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!-----------------------------------------------Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0...
2024-02-2056 min
The State of TMFCrafting a TMF Training Program for your TeamWe 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...
2024-01-1653 min
The State of TMFRisk-Based TMF Management 101Risk-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, Dawn Niccum, to discuss the past, present and what all TMF'ers need to know about the imminent future of risk-based TMF. Plus, get a FREE copy of our brand-new white paper detailing our approach to risk-based TMF management.-----------------------------------------------Subscr...
2023-12-1950 min
The State of TMFTrackers & 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 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'l...
2023-11-2854 min
The State of TMFTMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023Our 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 -> https://hubs.ly/Q01Hy0NW0Join our community -> https://hubs.ly/Q027nggP0 Read the State of TMF Industry Report 2023 -> https://hubs.ly/Q027nlrf0
2023-11-0151 min
The State of TMFInspection 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 of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0
2023-09-0535 min
The State of TMFIs 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 system.Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0
2023-08-1645 min
The State of TMFOnce Upon a TMF: Boosting Inspection Readiness with StoryboardingIn 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
2023-08-0254 min
The State of TMFLights, Camera, Inspection: Performing Oscar-Worthy Mock InspectionsIn 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 -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0
2023-07-1952 min
The State of TMFThe New Inspection Frontier - Navigating Remote & Hybrid GCP InspectionsIn 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
2023-07-0550 min
The State of TMFSet Yourself up for Inspection Success: Leveraging TMF Health Checks & OversightThe 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 listen now!Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0
2023-06-2256 min
The Huxley Morton PodcastFrom Pharma to Tech: How Montrium’s CEO is Revolutionizing Compliance in the Life Sciences Industry | Ep 59In this episode, we had the pleasure of speaking with Paul Fenton, the CEO of Montrium, a leading provider of GxP compliance and content management solutions for the life sciences industry.
Paul shared with us his journey of starting his career in the pharmaceutical industry and how his passion for compliance and technology led him to co-found Montrium in 2005. Since then, Montrium has grown to become a trusted partner for life sciences companies worldwide, with a focus on delivering innovative solutions that streamline processes and ensure regulatory compliance.
Throughout our conversation, Paul shared his insights...
2023-05-1057 min
The State of TMFMergers, Acquisitions & Shelved Compounds: Dealing with TMFs with Steph Viscomi & Dawn NiccumIn 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
2023-05-031h 01
The State of TMFNumbers don't lie - Building a TMF Metrics Program from the Ground UpMetrics, 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.Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0
2023-04-1948 min
The State of TMFYou've got mail - Building an intuitive process for TMF correspondence.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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join...
2023-04-051h 03
The State of TMFConfessions of an Ex-TMF Manager - Breaking Bad Habits with Note to Files.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 (NTFs) 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.Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0Join The State of TMF Community -> https://hubs.ly/Q01...
2023-03-201h 02
Latinos In Clinical ResearchMontrium Joins LICR To Discuss Trial Master File Tech For Sites and Sponsors in Clinical Researchhttp://www.latinosinclinicalresearch.com
2021-10-1235 min