- Replay of the webinar recorded on Tuesday, November 10, 2026, in English.
- LLMs, AI agents and MCP explained, with the regulatory framework that already applies (GCP, GDPR, HIPAA).
- By default, an AI tool connected through the Datacapt MCP only reaches metadata (L0) and aggregated data (L1).
- Live demo: study build, CDASH-compliant items, ePRO translation and an AI-generated study report.
AI in clinical trials, explained and shown live
LLMs, AI agents, MCP: these terms now come up in every clinical operations meeting. Many teams still find it hard to see what they mean in practice and where AI helps on a real study.
In this webinar, Florentin Ory (CEO & Co-Founder) and Khalil Ben Yahia (Clinical Trials Expert) explain the key concepts in plain terms, then show real use cases live in the Datacapt EDC through the Datacapt MCP.
Watch the replay
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What you’ll see
1️⃣ AI, LLMs, AI agents and MCP explained
What each term covers, and why MCP lets any AI assistant connect to a clinical system such as an EDC.
2️⃣ The regulatory framework
GCP (ICH E6(R3)), GDPR and HIPAA already apply when you use AI in a study. In 2026, the FDA and the EMA also published, for the first time together, ten guiding principles for good AI practice in drug development.
3️⃣ Two myths about AI in clinical research
Does connecting an AI tool open access to all your data? Will AI replace jobs? Khalil and Florentin answer both from what they see with sponsors and CROs.
4️⃣ Data access levels, from L0 to L3
Metadata, aggregated data, pseudonymized individual data and identifying data: which level an AI tool can reach, and under which conditions.
5️⃣ Live demo in the Datacapt EDC
Build a study from a prompt, create items with CDASH-compliant codes, translate an ePRO and generate a study report with a heat map per site.
Format
Recorded on Tuesday, November 10, 2026
- Concepts and regulatory framework
- Live demo in the Datacapt EDC
- Q&A with participants
Why watch?
See what AI can and cannot do in a clinical trial today, and how to keep human oversight, traceability and control over your study data.
When was the webinar recorded?
On Tuesday, November 10, 2026.
How long is the replay?
About 50 minutes, Q&A included.
Who presents the session?
Florentin Ory, CEO & Co-Founder of Datacapt, and Khalil Ben Yahia, Clinical Trials Expert.
Can an AI tool access all my study data through MCP?
No. By default, it only reaches metadata (L0) and aggregated data (L1). Pseudonymized and identifying data (L2 and L3) require an AI tool validated for your regulatory context, such as GDPR or HIPAA, or hosted in your own infrastructure.
How do I watch the replay?
Fill in the form on this page. You will be redirected to the video.
Florentin combines clinical research know-how with a true passion for product design. Attentive to detail and obsessed with user experience, he ensures that Datacapt remains a high-performance platform that’s also intuitive and accessible to every user.
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