AI in Clinical Trials & Regulatory Affairs: Automation, Ethics & Compliance

Clinical research generates significant amounts of data, documentation, monitoring activity, and regulatory work. AI and automation can potentially support parts of these processes, but healthcare and clinical research require strong governance and oversight.

This session explores where AI can assist clinical trial and regulatory workflows and where human judgment remains essential.

Participants will examine opportunities alongside important considerations involving privacy, ethics, data integrity, validation, explainability, regulatory requirements, and patient safety.

What participants will explore: AI applications in clinical research; clinical trial data and documentation; automation of repetitive processes; trial-monitoring support; regulatory workflows; responsible AI; privacy and data governance; validation and auditability; human-in-the-loop processes; and ethical considerations.

Focus Area: Clinical Operations & Compliance

Recommended Presenters: Clinical Research Director/CRO Professional + Regulatory Affairs Lead