Кращі подкасти про TMF (2025)

1
Quality by Design: Bridging the TMF - Quality Gap in Your Study 52:38

3d ago52:38

52:38

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 discussion is our President & CEO, Paul Fenton-Carter, and…

1
ICH E6(R3): The Birth of the (Digital) Record 45:06

2M ago45:06

45:06

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 Epist…

1
Bridging Files - A look at the ISF Reference Model 51:15

3M ago51:15

51:15

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 address…

1
Ask Paul - Our CEO Answers Your Most Pressing TMF Questions 39:48

5M ago39:48

39:48

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…

1
Setting New Standards: What's in V4 of the TMF Reference Model? 57:37

5M ago57:37

57:37

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-l…

1
Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF 49:45

6M ago49:45

49:45

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 current gaps that prevent TMF from being truly digita…

1
More than an Archive - Moving to an Active TMF Management Model 42:58

10M ago42:58

42:58

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 compili…

1
Battle of the Binders: What's the Difference Between the TMF & the ISF? 55:41

12M ago55:41

55:41

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 spec…

1
Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews 52:56

1y ago52:56

52:56

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 reviews, the "why" and "how" of routine ATRs, which h…

1
Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study 33:20

1y ago33:20

33:20

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 Ac…

1
Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged 56:30

1y ago56:30

56:30

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…

1
Crafting a TMF Training Program for your Team 53:12

1+ y ago53:12

53:12

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 real about some of the training struggles they've …

1
Risk-Based TMF Management 101 50:07

1+ y ago50:07

50:07

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, Dawn Niccum, to discuss the past, present and what al…

1
Trackers & Logs in the TMF: Where to file them? 54:38

1+ y ago54:38

54:38

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 y…

1
TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023 51:59

1+ y ago51:59

51:59

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 -> https://hubs.ly/Q01Hy0NW0 Join our community -> …

1
Inspection readiness toolset - What tech do we need for the future? 35:56

1+ y ago35:56

35:56

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/Q01Hy0NW0 Jo…

1
Is eTMF tech working for small companies? 45:59

1+ y ago45:59

45:59

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 ->…

1
Once Upon a TMF: Boosting Inspection Readiness with Storyboarding 54:25

1+ y ago54:25

54:25

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/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0…

1
Lights, Camera, Inspection: Performing Oscar-Worthy Mock Inspections 52:11

2y ago52:11

52:11

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 -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to ke…

1
The New Inspection Frontier - Navigating Remote & Hybrid GCP Inspections 50:32

2y ago50:32

50:32

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 Subscribe to The State of TMF Live Events -> http…

1
Set Yourself up for Inspection Success: Leveraging TMF Health Checks & Oversight 56:55

2y ago56:55

56:55

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 listen now! Subscribe to The State of TMF Live Events -…

1
Mergers, Acquisitions & Shelved Compounds: Dealing with TMFs with Steph Viscomi & Dawn Niccum 1:01:25

2y ago1:01:25

1:01:25

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. Subscribe to The Sta…

1
Numbers don't lie - Building a TMF Metrics Program from the Ground Up 48:45

2y ago48:45

48:45

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 S…

1
You've got mail - Building an intuitive process for TMF correspondence. 1:03:46

2y ago1:03:46

1:03:46

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 …

1
Confessions of an Ex-TMF Manager - Breaking Bad Habits with Note to Files. 1:02:03

2y ago1:02:03

1:02:03

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…

1
Ep 2 of Awesomest TECH News!! 19:11

2+ y ago19:11

19:11

Today's second episode, I'll talk 'bout TEN different TECH News found off Google recently, & I hope ya good people enjoy listenin' and watchin' it/Me! Oorah! I have Autism & other muti-disabilities by the way, and that's OK. God bless y'all, later

1
8 wellness tips from our dog 🐕‍🦺🥰 10:19

3y ago10:19

10:19

In this episode, I discuss 8 wellness tips from our dog Gage. Just watching her navigate life, we have a lot we can learn from our pets. Hope you Enjoy this episode.

1
Cuomo Snacks (Ep 2-28) 1:01:58

3+ y ago1:01:58

1:01:58

Yum Yum, New York's governor had to resign recently. Was it justified? Believe all women, what are your thoughts when you hear that statement? Check to see if that lines up with our thoughts. You might be surprised! Can men still compliment women? You just gotta listen to this episode... Tell us why you mad! T Staples - @ThomasStaplesIs Freddie B -…

1
Equality is Here! Women Are Picking Up The Bill! (Ep 2-27) 1:24:42

3+ y ago1:24:42

1:24:42

As we try to fight toward "Equality" for better or for worse... How does that look on the path toward marriage? Is it still necessary for men to pick up the bill? Should women now be expected to pick up that dinner bill and how does all this play into being married? What is the way to combine a traditional relationship with a modern one? Or can you…

1
Proof Kevin Samuels is KILLING Black Women (Ep 2-26) 1:20:35

3+ y ago1:20:35

1:20:35

Kevin Samuels is on the verge of being canceled? There is petition circulating to have Kevin Samuels "canceled" and taken off social media. Is that possible? Should Kevin even be considered for a "cancelation?" Or are people just butt hurt and refuse to accept accountability? Tell us why you mad! @ThomasStaplesIs @FreddieBTV @1_SuperDopeChick @DrBu…

1
Wemminz Be Trippin' - Sha'Carri's Fall & Tabitha Stings Wendy (Ep 2-25) 1:15:05

4y ago1:15:05

1:15:05

Wemminz Be Trippin! 😂 😂 😂 Today we're talking about Wendy Williams going at Tabitha Brown and try to figure out WHY. As well as Tabitha's reply... Tabitha shot back! Who's at fault with Sha'Carri Richardson situation? Is it Olympics fault? Her fault? ORRRRR someone elses? We get saucy on this one and you want to hear EVERYTHING we got to say about …

1
Can't Kill Bill......... Cosby (Ep 2-24) 1:10:19

4y ago1:10:19

1:10:19

All things Bill Cosby! Where do you stand on all things Bill Cosby? This case gets BROKEN down by the 4 members of the panel. Thomas plays a clip from Harvey Levin that puts ALOT of things in perspective in this case as well. Thomas pulls up a clip from an old podcast, YEARSS ago where Freddie B talks about Bill Cosby. Do the statements still ring …

1
It's Not You... It's Me(Ep 2-23) 1:14:08

4y ago1:14:08

1:14:08

How do YOU break up? Cut 'em off or drag it out? Or you make them break up with YOU? Today's INL (Innanets NEVA LOSS)T. Staples plays a clip of a popular movie on how to break up with your mate by a great actor of our time. Let us know if YOU agree with it all!!! ;-) Tell us why you mad! @ThomasStaplesIs - T Staples @FreddieBTV - Freddie B @1_Super…

1
Father's Day Isn't REALLY Important 😐😐😐(Ep 2-22) 51:57

4y ago51:57

51:57

Why aren't Fathers celebrated like Mothers? Or are they? Today's Internet NEVA LOSS (INL) we have three clips, one joke, commentary from Rickey Smiley Morning Show shutting down a lady wishing a single mother a Happy Father's Day and two men raised by single mothers, pontificating about the lack of respect Father's Day. Does it make sense to wish a…

1
Girl Vs. Guy Code (Ep 2-21) 1:44:17

4y ago1:44:17

1:44:17

The episode all about what men should be doing and what women should be doing! Today's INL (Innanets NEVA LOSS) we got a possible girl code violation story. Does girl code even exist? Was this one a violation by Jordyn Woods? Lil Duval drops some guy code violations. And Steve Harvey drops a situation. Check em out and decide... are these good exam…

1
Breaking up with added sugar 😊 7:59

4y ago7:59

7:59

Breaking up is always hard. It’s especially hard when you are trying to eliminate added sugar and highly processed foods from your diet. I discuss tips on how to get you over the hump.

1
Hot Vax Summer (We OUTSIDEEEEE) (Ep 2-20) 1:20:35

4y ago1:20:35

1:20:35

Summer 2021 is here and EVERYBODY IS OUTSIDEEEEE! In today's Innanets NEVA LOSS (INL) T Staples plays some clips about the viral trend of everybody showing how "outside" they really can be. Last summer got canceled so you KNOW dam near every single adult human is gonna be outside to enjoy life. We also talking about the different vaccines; Pfizer, …

1
We'll Probably Cancel This Podcast Later...(Ep 2-19) 1:07:56

4y ago1:07:56

1:07:56

What is the best way to Cancel someone nowadays? What is Cancel Culture and has it gone too far? Today's Innanet NEVA LOSS (INL) is about Justine Sacco and her infamous tweet some years back. “Going to Africa. Hope I don’t get AIDS. Just kidding. I’m white!” Should she have been canceled? Or simple joke on Twitter? Who are some people that have bee…

1
PC Culture is Sofa King We Todd Did(Ep 2-18) 1:39:19

4y ago1:39:19

1:39:19

PC Culture is run amok and we are tired of it. But then again, we need to be nice to people! Where is the line with telling the truth and being nice/being a bully? Who knows but we definitely try to get to the bottom of it here. But FIRST! Starting off the show with today's Innanet NEVA LOSS (INL) T Staples plays the Piers Morgan fiasco clips conce…

1
Harnessing the 5C’s on your wellness journey 9:33

4y ago9:33

9:33

I discuss the 5C’s we utilize in tfal&chi wellness coaching and we how you can harness them on the journey to a sustainable healthy lifestyle

1
Make America Great Again and BUILD THAT WALL! (Ep 2-17) 1:37:43

4y ago1:37:43

1:37:43

We got another official attorney, Attorney Corletra Mance, to come on the show that practices Immigration Law to talk immigration! Should we BUILD THAT WALL? What are some of the benefits of immigration? Or maybe you're like the host and just want to know what to make of all this immigration talk? DACA? Dreamers? Huh? Our special guest also drops s…

1
Where the (Online) Hoes at? (EP 2-16) 1:31:00

4y ago1:31:00

1:31:00

Yall be Online Dating? What's the best one? In today's Internet NEVA LOSS (INL) we hear a story about a girl that gets SCAMMED! 😂 😂 😂 The three hosts talk about their online dating stories. One host hit the bullseye and one host has crashed and burned and one host haven't even even been on them. Tell us why you mad! @thomasstaplesis @FreddieBTV @1_…

1
Stop Simpin!!!(Ep 2-15) 1:52:42

4y ago1:52:42

1:52:42

Our co-host on today's show is Courtney Michelle aka The Southern Belle and we have a SPIRITED convo about men and women relationships. It also gets quite SPIRITED between Courtney and T. Staples. Also, Are women today where they need to be with respect to getting a husband or are they destined to die alone? And simping obviously need to be killed …

4y ago1:27:07

1:27:07

In today's Internet NEVA LOSS (INL)... Did you know there's a difference between 1862 Land Grant colleges and 1890 Land Grant colleges? Guess which land grant colleges has gotten all their money from the government? Guess which one are the PWI schools and which one is the HBCU schools? Guess which one ALSO gets the money allocated for the OTHER gro…

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