Scientific and technological advancements in recent decades have fundamentally transformed clinical trials through digitisation and innovation in trial design and implementation. This has given rise to a new data normal where the volume, velocity, and variety of data are continually increasing, and this new landscape demands modern and robust data management practices for governance, personnel, processes, and technology. This raises the question of how industry and regulators adapt data management and governance to keep pace. A proactive approach to managing associated risks will help regulators accept data. This paper provides a comprehensive picture of the digital revolution in clinical trials, including relevant regulatory developments, while highlighting the opportunity to enhance drug development’s efficiency, accuracy, and cost-effectiveness.