This week, on May 14–15, the CDISC + TMF EU Interchange 2025 will take place, just a few steps from our Cytel’s Geneva office.

This year at Cytel, we’re making the event even more special! We will be hosting a pre-conference, open to anyone able to arrive into Geneva before the event begins.

But that’s not all, together with my Cytel colleagues we will have three presentations and one poster, where my colleagues will share insights from their work with CDISC standards, including the Trial Master File Standards Model (CDISC-TMF). And it is from the contribution of my colleague Caroline Terril that I’d like to start with some anticipations of what the four Cytel presentations will be about.

Key Considerations for Biometrics CROs Not Managing the TMF — The Journey So Far

Caroline Terril, Thursday, May 15, 10:00–10:30 — Session 5E: TMF Management (TMF Track)

If you’ve ever asked yourself after these last three years what really matters when it comes to managing the TMF with CDISC — especially for biometric CROs that don’t directly manage TMFs — then my colleague Caroline Terril might have the answer. In her presentation, she will delve into our journey so far in trying to adopt the CDISC-TMF standard.

The Curious Case of External Controlled Arms (ECA): Practical Solutions for External and RWD Integration

Gautham Selvaraj (co-authored by me), Wednesday, May 14, 09:30–10:00 — Session 5C: Real World Data

At Cytel, we’ve seen increasing use of external control arms (ECA) in sponsor projects. In this presentation, Gautham Selvaraj will walk through two real-world case studies on integrating ECA data into CDISC-compliant datasets, exploring the unique challenges and solutions in aligning real-world data with CDISC standards.

Interested in learning more about ECA clinical trial design? Explore more of Cytel’s offerings and insights:

• Early Planning Strategies for External Control Arms in HTA and Regulatory Submission
• Oncology Trials: External Control Arms and Bayesian Borrowing (Webinar)
• Cytel Solutions for Real-World Data in ECAs

Governing the Ungovernable: Can a CRO Effectively Govern Its Standards?

Angelo Tinazzi, Thursday, May 15, 14:30–15:00 — Session 7C: Applied Standard Governance

Are you a CRO struggling with different Sponsor Interpretation of Data Standards? Or perhaps across multiple therapeutic areas or indications? Hard life, isn’t it?

Spoiler alert: although there’s no “magic” in my presentation, and no AI involved, I will offer practical insights into the complexities of CRO data standard governance. Sponsors are also welcome to join to see what life looks like from the other side of the barricades!

Managing SDTM Mapping Challenges in Multi-Study Portfolios: A Guide to Standards and Consistency

Jing Zhang and Marianne Dutfoy, Wednesday, May 14, 12:30–13:30 — Poster Session

In their poster, Jing Zhang and Marianne Dutfoy offer guidance for navigating SDTM mapping across multi‐study portfolios. They’ll address challenges such as inconsistent CRFs, variations in source data, and the hurdles of aligning historical studies with newer versions of standards.

Interested in learning more?

Download Angelo Tinazzi’s new ebook, “The Good Data Submission Doctor on Data Submission and Data Integration to the FDA”:

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