TMF Daily
Hey, TMF Tribe! Nicole Palmer here, and I’ve got something special for you. Introducing the TMF Daily Podcast – where we talk all things TMF! Get ready for a unique experience. This isn’t your typical podcast; it’s a daily rendezvous with the industry disruptors of clinical research. We’re talking Trial Master Files, compliance, innovation, and the inside scoop you won’t find anywhere else. Join me and industry experts for a dose of wisdom, insider insights, and strategies that will revolutionize your understanding of clinical trials. Don’t miss out! Hit that subscribe button now and join the TMF Tribe. It’s time to amplify your impact, TMF listeners! Let’s do this!
Episodes
In today’s powerful episode of the TMF Daily Podcast, I sit down with a LEGEND in the clinical research space—Sholeh Ehdaivand.
She’s not just a TMF expert… She’s the founder behind LMK Clinical Research Consulting, one of the most recognized TMF consultancies in the world.
Sholeh built her company from the ground up, led global trials, coached teams into compliance greatness, and then made a bold move—she exited the company she bu...
AI Can Translate Everything… Right? Duncan Shaw Explains Why That Thinking Could Cost You Millions
We’re living in a world where automation gets all the applause. But in clinical research, one mistranslation can derail a trial—or worse, jeopardize patient safety.
In this episode of the TMF Daily Podcast, we sit down with Duncan Shaw, President and Owner of DTS Language Services, a leader in high-accuracy translation for life scienc...
Today’s episode is not just about TMF culture — it’s about how to BUILD movements inside highly regulated spaces. Oliver is the Head of Marketing at Epista Life Sciences, but his real superpower? Disrupting the status quo and turning compliance-driven teams into purpose-fueled powerhouses.
If you’ve ever felt like TMF is just a checklist… or wondered how to inject life, leadership, and loyalty into your trial teams… this conversati...
On today’s episode of the TMF Daily Podcast, we’re turning up the volume on something that can make or break your clinical research career:
NETWORKING—but not the boring kind. We’re sitting down with Elizabeth Tabor, the powerhouse CEO and Founder of the Clinical Research Referral Club (CRRC)—a disruptive force who is transforming how professionals, businesses, and even patients connect in this industry.
This episode is a MUST-LIST...
TMF Elite, are you ready to ditch outdated processes and take back your time? Today’s episode is a game-changer for clinical research professionals drowning in manual document management.
We’re talking real transformation—how AI isn’t just another tool but the ultimate advantage in clinical operations. And I’ve got the perfect guest to break it all down. Angie Schwab is a true innovator in AI-driven document management. As the pow...
You might think signing in and out of a study is just a small formality. But let me tell you—this ‘small’ thing separates TMF experts from liabilities. It’s the difference between a smooth audit and your name showing up on a deviation report.
In this episode, we’re diving into WHY this simple habit can make or break a clinical trial. You’ll learn:
✅ How missing sign-ins lead to audit findings and compliance risks. ✅ Why traceabili...
Alright, TMF fam—it’s go-time! 🔥 Study closeout (AKA the end of a clinical trial) is where the winners shine. If you're a Clinical Research Associate (CRA) or Clinical Trial Manager (CTM), this is your final shot to lock in compliance, secure that TMF, and leave ZERO room for errors.
In this video, we’re breaking down: ✅ CRA & CTM key responsibilities at study closeout ✅ How to finalize the TMF for inspection readiness 📁💯 ✅ ...
Hey TMF Elite! Today we're dropping MAJOR value bombs about something that's going to transform your ETMF career - Protocol Knowledge! Whether you're an experienced specialist or just starting out, this episode is packed with game-changing insights you can't afford to miss! 💎
In This Value-Packed Episode:
✅ The TRUTH about protocols every ETMF specialist needs to know
✅ How understanding protocols can make you IRREPLACEABLE
✅ Care...
Today we're breaking down something in clinical research that most professionals overlook – the Delegation of Authority Log! If you've ever wondered how top clinical research professionals CRUSH their inspections and lead high-performing teams, this episode is for you.
What You'll Learn:
✅ The TRUTH about DOA logs (it's not just paperwork!)
✅ How to build INSPECTION-READY documentation
✅ Leadership secrets that will set you apart
✅...
Hey TMF Daily family! Nicole here, and today we're breaking down something that might sound technical, but is ABSOLUTELY game-changing for anyone in clinical research. Ever wondered how top professionals stay ahead of the game? How they crush regulatory inspections and make complex trials look EASY? The secret is the Electronic Trial Master File (eTMF).
In this episode, you'll discover:
✨ What EXACTLY is an ETMF is (and why it's no...
Welcome to another powerhouse episode of TMF Daily Podcast! Today, we’re pulling back the curtain on FDA Form 1572—the document that’s often misunderstood but absolutely critical to every clinical trial.
Think it’s just a form? Think again. The 1572 is a legal agreement, a compliance cornerstone, and a bridge to global regulations. We’re connecting the dots between the FDA’s perspective, EMA requirements, and ICH GCP guidelines to ...
Welcome to TMF Daily Podcast, where we turn the TMF chaos into clarity! Today, we’re tackling the topic: Essential Documents in the Trial Master File (TMF).
Think of essential documents as a chapter book. They tell the story of your study’s design, execution, and results, keeping you aligned with regulations and ready for inspections. But what exactly are these documents, and why are they so critical?
In this episode, we’re breakin...
If you’re ready to dominate the clinical research game and become a TMF powerhouse, here’s what you do next:
➡️ Share this episode with your team, your network, and anyone who needs to step up their TMF knowledge. ➡️ Drop your biggest takeaway in the comments or DM me—let’s talk about how YOU are leveling up! ➡️ Follow TMF Daily Podcast so you never miss the insights that could change the way you work.
You’re not just here to learn...
Today, we’re thrilled to welcome a phenomenal guest all the way from Denmark—a key player in the TMF Network, a group that’s revolutionizing how companies approach inspections and compliance.
In this episode, we dive deep into the history and mission of the TMF Network, explore how their innovative meet-ups and roundtables are shaping the industry, and uncover strategies to foster growth, resilience, and impactful leadership.
Our g...
Welcome back to another power-packed episode of the TMF Daily Podcast! I’m your host, Nicole Palmer, and today we’re diving into a game-changer for clinical trials—AI’s role in authoring regulatory documents.
Imagine a world where documents are streamlined, more accurate, and faster to produce… and it’s not all human hands doing the work!
But here’s the twist: with AI stepping in, we’re now asking the big questions—how do we regula...
Today, we’re diving into an important topic that’s all about career progression within the Trial Master File (TMF) world. Maybe you’ve been a Clinical Trial Assistant for years, you’re ready to grow, take on new responsibilities, and learn some fresh skills to elevate your career.
We’ve got a special guest today, Karla Navera Anderson—a Clinical Trial Manager with extensive TMF experience, and one of the most sought-after TMF speak...
Joining me today is John Nocero, an expert who will show us why the TMF is not just a box to check off but an industry standard that demands perfection every single time.
We’ll kick things off with what a “Quality TMF” means and why it’s a game-changer. John will break down the critical components that must be in place, the common pitfalls to avoid, and the real-time strategies that ensure your TMF is always audit-ready.
We’ll also...
In this episode, I’m joined by the brilliant Juan Garza, a seasoned expert in the TMF. Juan will be walking us through the key performance indicators (KPIs) that can elevate your TMF strategy.
We’ll explore which metrics truly matter, how to track them effectively, and what they reveal about the overall health of your TMF.
Whether you're new to TMF or looking to refine your approach, this episode will give you actionable insights o...
In this episode, we dive into the world of clinical trial operations with special guest, Dennis Harris, an expert in Trial Master File (TMF) management and operations. 🚀
📂 What exactly does a TMF of operations do? Dennis breaks it down for us, explaining how TMF operations play a crucial role in ensuring the organization, integrity, and compliance of essential trial documents. We’ll cover everything from maintaining documentati...
Welcome back, TMF Elite!
On today’s episode of the TMF Daily Podcast, we’re diving deep into the world of Trial Master File careers with an incredible guest, Ann Ackley-Fifer. Ann is a powerhouse in the TMF field—there’s nothing she can’t do, from being a lead resource and evaluating processes to system configurations and migrations. If you’re looking to level up your TMF career, this episode is a must-listen!
Join us as we explore...
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