06.13.26 -- May's Best: AI, Rare Disease Trials, eConsent, And More

For any trial conducted in the EU/EEA, regulators want to know that AI used across clinical trial planning, conduct, and analysis is transparent, controlled, and fit for purpose. Jessica Cordes explains how even U.S.-based teams must meet EMA expectations.

With FDA's Claude-to-Gemini transition underway within Elsa, Kimberly Chew, Esq., and Michael Yang, Esq., offer advice for proactive risk management to safeguard trade secrets and regulatory outcomes in part three of this series on Elsa's AI transition.

Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than measures, such as ir-RECIST.

Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.

Rare disease trials demand inventive design. Uncover creative strategies that help sponsors overcome tiny populations, complex endpoints, and operational hurdles to advance meaningful breakthroughs.

This on-demand session offers a clear, practical overview of the major eSignature types used in eConsent and explains when each is appropriate.