Advanced Clinical Trials and Clinical Research

Decentralized Trials

Decentralized clinical trials (DCTs) are transforming the research landscape by moving studies beyond traditional site-based settings. This session delves into the operational, regulatory, and technological frameworks enabling virtual and hybrid trials. Topics include remote patient monitoring, telemedicine integration, home health visits, and ePRO/eCOA adoption. Attendees will explore case studies demonstrating improved patient access, faster recruitment, and higher retention rates in decentralized models. Regulatory guidance from the FDA, EMA, and other authorities will be reviewed to address compliance and data validation challenges. The session will also cover vendor selection, logistics coordination, and ensuring data integrity across decentralized nodes. As clinical trials become more global and patient-centric, this session provides actionable strategies for designing, implementing, and managing successful decentralized studies that enhance inclusivity, reduce costs, and maintain scientific rigor.