Talk Clinical Data Competencies & Cross-Functional Interactions · Technology & Data Platforms
The Role of ICH-M11 and Digital Data Flow (DDF)
Mon, Sep 29, 2025 · 3:05–4:05 PM EDT Ballroom I-II, Baltimore Convention Center
About this session
Session chaired by Kimberly Tableman
Description:
This thought leadership panel brings together CDISC, OpenClinica, ThoughtSphere, and ESPERO to explore how emerging standards like ICH-M11 and USDM v4.0 are transforming protocol development and downstream interoperability. With CDISC’s 360i initiative guiding the next era of standards, we examine how structured, reusable protocol content can drive automation across EDC, IRT, and eCOA systems—moving us beyond static documents into dynamic, data-powered ecosystems. Speakers will share real-world insights on implementation, resistance to change, and the cultural and technical shifts needed to make interoperable trials a reality.
