02.14.26 -- Best Of January

Former FDA investigator Alia Legaux, D.H.Sc., runs through her top tips for running a mock investigation.

AI-assisted reviews are changing FDA submissions. In part two of this series, discover how sponsors can address and even preempt regulatory and legal concerns.

Part 2 of this 2026 forecast series dives deeper into the operational friction points the clinical trials industry still hasn’t resolved. Industry leaders weigh in on sponsor–site partnerships under strain, the growing tech burden on sites, consolidation across site networks and platforms, the limits of AI hype, and why human connection may end up being the most important “innovation” of all.

Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.

In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

Matthew Peruhakal, Global Head of Data Architecture, Utilization, and AI Engineering at Sanofi, offers a deep look at how the pharmaceutical giant is integrating AI to transform clinical trials.

Join Clinical Leader Live Chief Editor Dan Schell on February 18, at 1pm Eastern, for this anticipated discussion on AI that will go beyond the buzzwords to focus on what’s actually working in clinical operations. You will hear about some of the newest real-world applications, lessons learned from early adopters, and how to spot hype before it costs you time or money. Register for free thanks to support from our sponsors.