Strategic Change Management for AI Adoption in Clinical Trials

This guide outlines a discovery-driven approach for implementing AI in clinical trials, emphasizing the importance of addressing organizational and process challenges prior to technology deployment. It identifies various elements contributing to variation in clinical research, including organization types, processes, tools, communication methods, and role scopes. The document stresses the need for a robust AI strategy that considers skillset recombination and regulatory hurdles before initiating change management efforts. It presents a strategic implementation approach divided into phases, focusing on comprehensive assessment, managed deployment, and foundation building. Key success factors include understanding operational realities, addressing complexity in standardized processes, enhancing skills, and involving all stakeholders to ensure alignment and shared ownership. The guide aims to reshape clinical research by prioritizing social enablers that facilitate AI adoption over mere technological capabilities.