Governed AI in Clinical Trial Regulatory Compliance

This white paper discusses the role of governed AI in meeting the regulatory requirements of modern clinical trials. It outlines the increasing complexity and data richness of clinical trials, highlighting the evolving expectations from regulatory bodies regarding governance, risk management, and oversight. The paper explains how assistive AI, when combined with centralized data management systems, can enhance compliance by facilitating risk-based monitoring and ensuring audit-ready documentation. It details the new regulatory frameworks established by the International Council for Harmonisation and the U.S. Food and Drug Administration, emphasizing the sponsor's responsibility for oversight and compliance even when tasks are delegated to third-party vendors. The document also addresses the challenges faced by sponsors due to outdated systems and fragmented oversight processes, and it presents modern technologies, including AI, as solutions for improving trial management and documentation practices. Overall, the paper emphasizes the importance of proactive quality management in clinical trials.