Not many artists actually hail from Tennessee, but the scenic valleys and rolling hills of The Volunteer State are part of Dustin Lynch’s DNA. In this episode of On the Bus, Country Thunder CEO Troy Vollhoffer sits down with Dustin to discuss his journey from playing fraternity parties and weddings across the southeast to being the first country artist with a club residency at the Wynn in Las Vegas. Plus, stick around for our new segment, Thunder Strike, where Troy features upcoming festival performer Riley Green’s hit song “Damn Good Day to Leave” to give you a taste of what’s to come at Country Thunder in 2025.…
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محتوای ارائه شده توسط Montrium. تمام محتوای پادکست شامل قسمت‌ها، گرافیک‌ها و توضیحات پادکست مستقیماً توسط Montrium یا شریک پلتفرم پادکست آن‌ها آپلود و ارائه می‌شوند. اگر فکر می‌کنید شخصی بدون اجازه شما از اثر دارای حق نسخه‌برداری شما استفاده می‌کند، می‌توانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
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Numbers don't lie - Building a TMF Metrics Program from the Ground Up
Manage episode 362338009 series 3472771
محتوای ارائه شده توسط Montrium. تمام محتوای پادکست شامل قسمت‌ها، گرافیک‌ها و توضیحات پادکست مستقیماً توسط Montrium یا شریک پلتفرم پادکست آن‌ها آپلود و ارائه می‌شوند. اگر فکر می‌کنید شخصی بدون اجازه شما از اثر دارای حق نسخه‌برداری شما استفاده می‌کند، می‌توانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
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.
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
24 قسمت
اشتراک گذاریManage episode 362338009 series 3472771
محتوای ارائه شده توسط Montrium. تمام محتوای پادکست شامل قسمت‌ها، گرافیک‌ها و توضیحات پادکست مستقیماً توسط Montrium یا شریک پلتفرم پادکست آن‌ها آپلود و ارائه می‌شوند. اگر فکر می‌کنید شخصی بدون اجازه شما از اثر دارای حق نسخه‌برداری شما استفاده می‌کند، می‌توانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
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.
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
24 قسمت
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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 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 00:30 Welcome and topic intro 01:03 Guest intros (Joanne Malia and Karen Roy) 03:53 Important changes to the final version of ICH E6 R3 06:39 Areas where risk-based approach is useful 08:05 ICH M11 & digital protocol 10:21 Names changes, terminology & guidance documents 13:26 Question from the audience (Nomenclature) 15:20 ICH and the TMF Reference Model 17:25 Criteria /decisionguide 20:14 Timeline for TMF Ref Model V4 22:45 Essential records table & Records that go across studies 27:05 Questions from the audience 41:33 Wrap up 44:41 Outro _____________________________________________ Connect with Host and Guests: Paul Fenton-Carter : https://www.linkedin.com/in/paul-fenton-carter-360b531/ Joanne Malia: https://www.linkedin.com/in/jsmalia2008/ Karen Roy: https://www.linkedin.com/in/karenjroy/ _____________________________________________ TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-model Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 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 Lowery 00:35 Guest intros (Jamie Toth and Matt Lowery) 01:55 Topic Intro & History of ISF 04:20 ISF Initiative Overview and Timeline 10:32 ISF Facts 12:28 ISF Structure 21:09 A snapshot of final draft of the ISF Reference Model 22:39 Quiz Time 23:38 Final draft snapshot continued 25:25 Matt's take on packages and sub-packages 26:24 How does the TMF Reference Model align with the ISF 29:30 The three additional ISF artifacts 34:09 ISF Initiative ongoing and future activities & questions 48:51Wrap up and final thoughts 50:49 Outro ------------------------------------------------------------ Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Jamie Toth: https://www.linkedin.com/in/jamie-marie-t-759772/ Matt Lowery: https://www.linkedin.com/in/mattlowery/ ------------------------------------------------------------ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 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 the field. CHAPTERS: 00:00 Topic Teaser w/ Paul Fenton-Carter 00:28 Speaker and topic intros 01:36 Exploring how the role of the TMF manager is evolving 06:05 Examining the industry's progress in adopting risk-based TMF management 12:40 Insights on the rapid incorporation of AI and its impact on TMF management 18:02 Discussing the challenges of accurately measuring completeness 24:25 Understanding the importance of ICH M11 and its impact on TMF 31:00 Key considerations around ICH E6(R3) and its implications for TMF 37:39 Addressing common misconceptions about TMF 38:40 Wrap up 39:20 Outro _______________________________________________ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 impact these updates will have on clinical documentation management practices in the digital age. CHAPTERS: 00:00 Topic Teaser w/ Karen Roy 00:25 Topic intro 00:43 Speaker intros w/ Paul Fenton-Carter & Karen Roy 02:27 History of the TMF Reference Model 07:25 Regulatory Evolution and other factors 10:00 What is a Digital TMF 12:23 Benefits of becoming a Digital Standard 17:01 The Data Driven Approach & Digital Protocols 23:28 Heads of TMF and what they need to know about USDM 26:54 The future of TMF Reference Model V4 & Goals 35:09 The importance of standardizing Sub-Artifacts 43:51 V4 (TMF RM) Org Chart 51:15 How to get involved? 56:15 Wrap up 57:11 Outro ________________________________________________________________ CDISC Sign-In: https://www.cdisc.org/sign-in Paul Fenton-Carter email: pfenton@montrium.com Karen Roy's email: kroy@cdisc.org Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook : https://www.facebook.com/Montrium/…
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 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 enhancing quality, timeliness, and compliance, while revealing how it can unlock the vast goldmine of information stored within the eTMF to improve oversight and streamline clinical process management. CHAPTERS 00:00 Topic Teaser 00:50 Speaker intros 03:36 Topic intro 04:30 The Heart of Digital TMF and the new standard ICH M11 17:20 How will the new standards affect Sponsors and CROs? 19:41 Functions impacted outside of TMF with the new standard 25:00 Impact on the vendor ecosystem 29:24 The regulatory impact 34:50 How can Sponsor adapt to the new standard? 37:24 Will Regulatory bodies be lenient with the changes? 40:05 Regulatory processes 42:30 Hurdles Vendors and Sponsors might face with the implementation of M11 45:45 How to prepare for the changes 48:25 Wrap up 49:15 Outro _____________________________________________ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 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 how to leverage technology for real-time oversight and ensure your TMF team maintains an agile TMF mindset. --------------------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 LinkedIn: Register for for episode #9 @ TMF Week 2024 Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 high-risk data points you should be reviewing, and more! ----------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/ Register for TMF Week 2024: https://www.tmfweek.com/…
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The State of TMF
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 ----------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/ Daelight Solutions: https://daelightsolutions.com/…
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The State of TMF
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! ----------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/…
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 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 this episode is for you! ----------------------------------------------- Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/ Join us on Facebook: https -> https://www.facebook.com/Montrium/…
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 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. ----------------------------------------------- Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/ Join us on Facebook: https -> https://www.facebook.com/Montrium/…
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'll also get the chance to leave your own burning question(s) on the hot topic of risk-based TMF so we'll be sure to cover them in the next episode. You can fill out the super quick, 2-minute touchpoint by clicking this link -------------------------------------------------------------------------- Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/ Join us on Facebook: https -> https://www.facebook.com/Montrium/…
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 -> https://hubs.ly/Q027nggP0 Read the State of TMF Industry Report 2023 -> https://hubs.ly/Q027nlrf0…
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 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0…
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Player FM - برنامه پادکست
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