05.28.26 -- FDA's Elsa AI Shift, RTCT Rules, And RWE That Works

ISPOR’s Rob Abbott explains why RWE surged in HEOR, and how wearables, data fragmentation, and HARPER+ are reshaping modern clinical trial platforms.

After halting Claude for Elsa AI, the FDA’s move to Gemini raises new questions for sponsors on IP protection, trade secrets, and AI‑driven data security.

Panelists Aaron Kamauu, MD, and Kathleen Mandziuk, MPH, share practical ways to turn messy RWD into trusted RWE that streamlines trial design and timelines.

See how amendment drivers vary by therapeutic area and how anticipating operational pitfalls can reduce patient burden, site workload, and study delays.

As obesity and GLP‑1 trials surge, learn how to scale to 5,000‑patient registries and build compliant, long-term evidence with a new operational blueprint.

Africa holds 25% of the disease burden but just 1% of trials. See how CRIO and CREA-N use digital platforms to expand research access in underserved regions.

Learn how digital biomarkers, AI, and cross‑industry collaboration are driving continuous, real-world measurement and smarter clinical development.

Discover how a unified mobile app reduces participant burden, centralizes study tasks, and helps patients stay engaged from consent through follow-up.

Explore how rethinking end-to-end processes speeds secure data flow, removes bottlenecks, and turns trial operations into a high-efficiency engine.

Unified eCOA–IRT solutions streamline operations, reduce reconciliation, and improve data integrity, site experience, and patient engagement in modern trials.

TrialKit’s open APIs allow real-time data exchange and customized workflows so sponsors can adapt quickly without brittle integrations or added complexity.

Position your RFP as a strategic communication tool that guides vendors, clarifies expectations, and supports data-driven vendor decisions.