Montrium

ICH E6(R3) moved the goalpost on oversight. It's no longer about activity. It's about proving reasoning. We talked with four TMF leaders about what that means in practice: Document the rationale. Anusha R. from Moderna explains that oversight now demands you show how you evaluated risks on a study, not just that you completed the review. Trust and verify. Jared Brooslin from Intellia Therapeutics points out the sponsor-CRO relationship only works when you give responsibility but then actually check in to make sure the work gets done. Expand your oversight scope. Dr. Antje Dahlen from Forschungsdock highlights that oversight now covers the systems your service providers use, alongside your own systems and the full TMF including documentation kept in separate repositories. Stop faking completeness. Joanne Malia from Regeneron shares what one of her CROs figured out: instead of trusting the EDL to say "100% complete," they cross-checked documents already in the TMF against each other, catching gaps like a plan calling for weekly meeting minutes with only one on file. Read Christina Mantzioros' full article to see how these organizations are building frameworks that hold up. 👉 https://lnkd.in/gpaMWHDD

Is your TMF ready for an inspection tomorrow, or only when someone tells you it's coming? At TMF Week 2026, Paul Carter (CEO of Montrium, Chair of the CDISC TMF Reference Model Steering Committee) opened the event with a statement that's been on our minds ever since: "Inspection readiness is shifting from document completeness to evidence intelligence." With ICH E6(R3) reshaping how we think about essential records, and AI changing what's possible in oversight and risk detection, a lot of long standing TMF habits are quietly becoming liabilities. We pulled 7 signs your TMF approach might be behind the curve. Swipe through and see how many hit home. 👉 What would you add to this list? Let us know in the comments.

ICH E6(R3) is more than a regulatory update. It represents a fundamental shift in how the industry approaches inspection readiness. As clinical research becomes more complex, organizations are being challenged to adopt a more proactive, risk-based, and data-driven approach to quality. The future of inspection readiness will rely less on simply proving what happened and more on demonstrating how quality is embedded into processes, how risks are identified earlier, and how decisions are supported by meaningful insights. With new expectations around oversight, technology, and risk management, organizations will need to rethink how they prepare for inspections and maintain quality throughout the trial lifecycle. Want to explore how Montrium is preparing for R3? Check out our new capabilities and sign up for updates: https://hubs.ly/Q04pjRW10 But first, we want to know, according to you..

Sponsors and CROs often don't have clear boundaries. You end up duplicating the same review work over and over until it has no meaning. Define it upfront. In your TMF plan, your SOPs. Who does what. How it fits together. Risk-proportionate. Then stick to it. No duplication. No surprises. Just efficiency. Hear from Anusha R., Senior Manager, TMF Quality Oversight at Moderna, on what real sponsor-CRO accountability looks like at TMF Week. 👉 https://lnkd.in/gGHn4xH5

Think inspectors expect a perfect TMF? Think again. What they're really looking for is evidence of effective risk management: a risk-based framework, proactive issue detection, and traceability you can stand behind. Want the full story? Watch Paul Carter explain why perfection isn't the goal, and what matters instead - https://lnkd.in/gsQWr9h8

Most organizations have the risk signal and the outcome. What’s missing is the documented rationale in between those two. ⚠️ Under ICH E6(R3), inspectors don’t just want to see what happened. They want to understand why it happened. In our latest blog, Christina Mantzioros and Bart Budyn take you on an exclusive tour of upcoming Montrium eTMF Connect capabilities, including a case study and video walkthrough showing how risk-based oversight can be managed in a connected, audit-ready workflow. Read the full article: https://hubs.ly/Q04n6Z2x0

A big congratulations to Ann Ackley-Fifer, winner of our third TMF'er for Life sweatshirt! 🎉 Thank you to everyone who joined us live for Episode 3 of The State of TMF at TMF Week. The podcast is now taking a well-deserved summer break. 🏖️ If you missed any episodes, now's the perfect time to catch up. You can also register to be notified when we're back this fall with brand new conversations on the future of TMF. And don't worry, we'll have more chances to win exclusive TMF swag in future live episodes, so stay tuned for our return! Catch up and sign up here 👉 https://hubs.ly/Q04n5SSr0

The State of TMF Survey closes Friday. If you haven't shared your perspective yet, this is your last opportunity to help shape this year's report. We're exploring how teams are putting ICH E6(R3) into practice, including risk-proportionate oversight, inspection readiness, and practical approaches to compliance. If you work in TMF, Clinical Operations, Quality, or Regulatory, we'd love to hear from you. As a thank you, you'll receive priority access to the report before it's publicly released, and you'll be entered to win our TMF Classics Kit, featuring a custom pair of TMF'er Converse and a mechanical keyboard. Take the survey here: https://lnkd.in/gNk57_K4 🗓️ Survey closes July 10.

The State of TMF podcast is taking a well-deserved summer break! 🏖️ Before we step away, here's a quick look at the important topics Paul Carter and Christina M. have covered this season so far: Ep.1: The CRO TMF Handoff Spotting TMF issues before your CRO sends the final package. Ep.2: Documents Without a Plot Why a complete TMF doesn't always mean a clear one. Ep.3: TMF Risk Assessment: Let's Stop Winging It A smarter framework for evaluating TMF risk. Catch up on past episodes and register to be notified once we're back this fall with fresh new episodes: https://hubs.ly/Q04n5SSr0

Risk-driven. Proportionate. Documented. Understanding the standard isn't the challenge. Turning a risk signal into a documented response, and making that documentation part of your daily workflow instead of a pre-inspection scramble, is where most sponsors get stuck. At TMF Week 2026, our Director of Product & Clinical Intelligence, Christina Mantzioros, gave an early look at how eTMF Connect is being built to close that gap. This article expands on the session, with the scenario, the mechanics, and the Q&A. 🔗 https://hubs.ly/Q04n6Z2x0