SCDM 2025 Regulatory Town Hall: Aligning Global Standards For ICH E6(R3) And Artificial Intelligence

By Marc Wartenberger

Global regulatory frameworks are evolving rapidly, and two areas are at the forefront: the upcoming ICH E6(R3) guidelines and the integration of artificial intelligence in clinical data management.

These changes aim to strengthen patient safety, improve data integrity, and modernize trial oversight. ICH E6(R3) emphasizes risk-based approaches, transparency, and adaptability, requiring sponsors and sites to rethink compliance strategies. At the same time, AI introduces opportunities for automation and predictive analytics—but also raises questions about validation, accountability, and ethical use.

Aligning global standards with emerging technologies is critical to maintaining trust and regulatory harmony across regions. Organizations that proactively prepare for these shifts will be better positioned to streamline operations, reduce errors, and meet evolving expectations.

Access the full discussion to learn how regulatory leaders are shaping the future of clinical research and what steps you can take now to stay ahead.