360i Phase 2: The Journey of an Endpoint

About this session

Part of Session 2: CDISC Plenary - 360i Vision & Roadmap (Chair: Julie Smiley, CDISC).

Clinical trial endpoints are at the heart of every study, yet the information needed to define, collect, analyze, and review them is often fragmented across systems and processes. This session follows the "Journey of an Endpoint" through the clinical research lifecycle, using Progression-Free Survival (PFS) as an example to demonstrate how CDISC 360i Phase 2 connects study design, data collection, analysis, and submission through machine-readable metadata and end-to-end traceability.
Through demonstrations of digital study design, Data Definition Specifications, Digital Data Transfer Agreements (DTA), Analysis Concepts, and emerging standards innovations, attendees will see how connected standards can preserve study intent, enable automation, improve traceability, and provide a foundation for AI-enabled clinical research. The session offers a practical view of how CDISC 360i is advancing the vision of a fully connected digital study.

Speaker

• JS

  Julie Smiley

  CDISC

  Speaker