AI-Driven Study Orchestration and Implementation: Powered by CDISC Biomedical Concepts

About this session

Part of Session 3, Track B: Digital/AI Foundations (Chair: Srinivasa Rao Mandava, Merck).

The CDISC Biomedical Concept (BC) framework offers a robust foundation for interoperability. Yet, translating unstructured protocols into these standards manually creates a costly ""Interpretation Gap."" This proposal introduces an AI-driven methodology, leveraging comprehensive ""360i Vision,"" to operationalise the CDISC framework. By designating the BC as the ""Atomic Unit of Truth"" an anchor tying clinical intent directly to technical execution. This approach automates end-to-end study orchestration. The AI engine accurately maps standard BCs while simultaneously capturing sponsor-specific ""Biomedical Variants"" and proprietary legacy nuances. This metadata-driven synchronisation automates USDM enrichment, dynamic ODM-XML eCRF generation, and custom Data Review/ Monitoring Plan validation logic. Shifting the focus from manual programming to expert validation, this automated architecture drastically reduces the time, financial cost, and human effort required for study start-up, achieving database lock-readiness with unprecedented speed and precision.

Speakers

• CT

  Chetan Tamballa

  Saama Technologies

  Speaker

• MV

  Murugesan Vadivel

  Saama Technologies

  Speaker