The clinical trial landscape has undergone significant transformation with digital technology becoming increasingly central to trial design, data collection, and management. The recently updated International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) guideline, adopted in December 2024 and coming into effect July 2025, represents a major evolution in how regulatory bodies expect sponsors and investigators to manage computerized systems and data integrity in clinical trials.

You can find Part One of Matt’s paper here