The State of TMF Live Podcast
Welcome to the new State of TMF podcast. On this podcast, 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.
Upcoming Live Events
EP#10: Rethinking our Inspection Readiness toolset - What tech do we need for the future?
Wednesday, August 23rd @ 11am ET
Listen to previous episodes
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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.
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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.
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.
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.
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
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.
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.
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.
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.
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.
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Your Hosts
The State of TMF is hosted by industry veterans and experienced TMF'ers from Montrium
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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.
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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
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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.