USDM in Practice: Building Computable Study Definitions
Nov 12, 2026 · Session 1 of 3
Description
Held on 12 November 2026, the first session of Clymb Clinical’s Emerging CDISC Standards Webinar Series explored how the Unified Study Definitions Model (USDM) transforms clinical protocols into structured, machine-readable study definitions. The session covered USDM’s relationship with Biomedical Concepts, its alignment with ICH M11 and HL7 FHIR, and how reusable study metadata can drive consistent downstream artifacts across clinical workflows.
The presenters discussed adoption and implementation considerations, including using a single source of study metadata to support reliable AI-enabled automation. Practical demonstrations of SAP Builder and Data Mapper illustrated how USDM can inform structured statistical analysis planning and SDTM/ADaM mapping.
Presenters: Richard Marshall (Principal Consultant), Tanaya Kondejkar (Software AI Engineer), and Bhavin Busa (Principal & Co-Founder), Clymb Clinical.