From Protocol to CSR: Reimagining Clinical Trials with AI and Next-Gen CDISC Models

About this session

Part of Session 7, Track B: End-to-End Flow (Chair: Kent Letourneau, ICON).

Clinical trials are at an inflection point, where static standards must evolve into intelligent, executable frameworks. Emerging CDISC standards, including USDM, Biomedical Concepts, Analysis Concepts (AC/DC), and Analysis Results Standards (ARS), provide the foundation for this transformation.
This paper demonstrates how these standards move beyond compliance artifacts to become the backbone of agentic AI systems. Biomedical Concepts and USDM enable computable study definitions, while AC/DC and ARS formalize analysis intent and outputs, collectively powering AI-driven automation of SDTM, ADaM, TFL, and CSR generation, along with protocol optimization and real-time insights.
Through real-world implementations, we showcase software solutions that generate SAS and R code from standards-driven metadata, reducing manual effort, improving traceability, and enhancing quality. Aligned with the CDISC 360i vision, we demonstrate purpose-built solutions connecting study design through to submission.

Speaker

• BB

  Bhavin Busa

  Clymb Clinical

  Speaker