Reimagining Clinical Trials with FHIR-to-CDISC Interoperability

About this session

Part of Session 6, Track C: Integration/Interoperability (Chair: Jim Box, SAS).

As clinical research moves toward interoperability and automation, aligning healthcare data standards with regulatory submission requirements remains a challenge. HL7 FHIR is increasingly adopted across EHR systems to enable standardized access to real world clinical data, while CDISC standards (SDTM and ADaM) continue to underpin regulatory submissions. Bridging these paradigms is essential for enabling end-to-end digital clinical trials.
This presentation outlines a standards-based framework for implementing FHIR to CDISC mappings aligned with emerging CDISC and HL7 guidance. It demonstrates the transformation of core FHIR resources to SDTM domains and emphasizes reuse of CDISC metadata, alignment with CDASH, and integration with existing sponsor pipelines.
The framework addresses key challenges including semantic alignment, variability in FHIR implementations, and governance, with mitigation strategies aligned to evolving regulatory expectations. It further highlights benefits such as reduced site burden, minimized redundant data entry, accelerated study startup, and support for decentralized and real-world data enabled trials.

Speakers

• PS

  Prasoon Sangwan

  TCS

  Speaker

• AM

  Arka Mazumder

  TCS

  Speaker