From Digital Protocols to Executable Trials: Neuro-Symbolic Intelligence Enabling CDISC Digital Data Flow

About this session

Part of Session 5, Track B: Digital Data Flow (Chair: Erin Muhlbradt, NIH/NCI).

The promise of CDISC Digital Data Flow is compelling: if study intent is captured early in structured, standards-aware form, downstream processes can become faster, more consistent, and less dependent on manual reinterpretation, with greater reliability and less rework. In practice, many organizations still struggle to turn digital protocols into tangible value across study build, monitoring, biometrics, and submissions.
This presentation shares EDETEK experience applying neuro-symbolic intelligence to bridge that gap. Using AXIS.AI, structured protocol representations are aligned with CDISC standards and transformed into executable logic that supports CRF alignment, SDTM mapping, monitoring readiness, compliance checks, and biometrics deliverable preparation. We will discuss how AI assists with interpretation and authoring, while deterministic, standards-based execution ensures consistency, traceability, and inspection readiness across downstream workflows. Attendees will gain a grounded view of how Digital Data Flow can evolve from structured documents into live, standards-executable intelligence that supports both operational execution and regulatory delivery.

Speakers

• JC

  Jian Chen

  EDETEK

  Speaker

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  Shakthi Kumar

  Chief Strategy and Business Officer · EDETEK

  Speaker