Accelerating Clinical Development: From Synopsis to CSR with AI - PhaseV Trials

This session will present an AI-orchestrated, human-guided framework that connects clinical development activities from synopsis to CSR, reducing timelines from weeks to hours while maintaining quality, transparency, and regulatory readiness. Through a practical case example, learn how the framework:  

• Connects synopsis, protocol, SAP, SDTM, ADaM, TLFs, and CSR reporting into one traceable workflow 

• Accelerates study delivery by automatically propagating changes across interconnected documents, reducing manual handoffs, rework, and cross-functional inefficiencies 

• Maintains human oversight through configurable rules, review checkpoints, audit trails, and source-grounded validation