Expert Guide: ICH E6(R3), Safety Harmonization & Decentralized Trials
Analytical guide on operationalizing ICH E6(R3), harmonizing safety in oncology, expedited IND/CTA for seasonal vaccines, and compliance for decentralized stroke trials—practical steps, metrics, and predictions.
Robert Maxwell
Sep 10, 2025
stroke trial regulation
oncology safety harmonization
vaccine IND pathways
healthy volunteer oversight
