A year ago, I stepped down from the CDISC EU Committee and, guess what? Just few weeks later, CDISC chose Milan, my hometown, as next destination for CDISC + TMF EU Interchange.

May 20–21 is fast approaching, so be sure to check the agenda if you haven’t already registered. You may immediately notice a different style compared to most conferences, and that’s the influence of a city known for beauty and design (and I promise I’m not biased). But have you ever seen conference tracks with such artistic titles? “AI Espresso Shot,” “TMF Standards and Governance — Allegoria del Buon Governo,” “Uno Standard Da Mangiare (USDM),” “Protocolli alla Moda: The M11-USDM Collection,” just to name a few.

Together with my Cytel colleagues, we will have two presentations and one poster, sharing insights from our work with CDISC standards, including the Datasets-JSON and CORE.

JSON and CORE Unlocking Adoption

Silvia Faini (co-author: Hugo Signol, Sebastia Barcelo, Angelo Tinazzi),

Wednesday, May 20, 12:30-13:30 – Poster Session

In this poster, we share our experience working with both CDISC datasets-JSON and CORE. Using several anonymized studies, we assessed available tools, both SAS and R, for creating and importing datasets-JSON files We highlight criticality key challenges, risks, and a comparison of CDISC CORE outputs versus tools such as Pinnacle21 (for SDTM only).

Authenticity Matters: Preserving Standards Integrity from Clinical Data Models to Tiramisù

Angelo Tinazzi

Thursday, May 21, 12:00-12:30 – Session 6C: L’Architettura degli Standard

What started as a joke, trying to “cheat” my Belgian friends who always complain about the original alcohol-free Tiramisu recipe, evolved into a serious internal project. We analyzed metadata from more than 300 anonymized SDTM packages (with ADaM to follow), spanning multiple versions, therapeutic areas, and trial phases. Using these metadata, we explored how SDTM implementation and adherence to regulatory expectations, particularly FDA requirements, have evolved over time, assessing quality and consistency through quantitative metrics.

It Got Worse Than Expected: Three Years of Retrospective CBER Requests on SDTM, ADaM, and TFLs

Mark Malayas (co-author: Angelo Tinazzi)

Thursday, May 21, 14:30-15:00 – Session 7: Regulatory Eccellenza

In 2023, we presented at PHUSE-EU Connect an initial experience with a FDA CBER Vaccine submission, following some initial interactions with the FDA. We shared our concerns about requests that, in many cases, required retrospective changes to already concluded studies. But that was not all! Three years later, the situation evolved further, with increasing and often unexpected requests from the agency. Curious to learn more? Join Mark on Thursday.

Silvia Faini, CDISC E3C Vice-Chair, will also be moderating Session 6C: L’Architettura degli Standard, Thursday, May 21 from 11:00–12:30.

Meet us there

Cytel will also have a booth at the conference! Stop by with our presenters, but also with our Business Development colleagues.

We look forward to reconnecting with colleagues from around the world, meeting new peers, and exchanging ideas at CDISC + TMF EU Interchange 2026.

We hope to see you in Milan!

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