The Evolving Landscape of eSouce to Sponsor Integration: Challenges and Opportunities with CDISC Standards

About this session

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

Clinical research sites are increasingly adopting their own technology, EHRs, eSource tools, ambient voice transcription, creating both opportunity and friction when integrating data into sponsor systems. While CDISC standards provide a foundation, variations in data models, terminologies, and business practices across therapeutic areas and geographies expose real gaps, particularly as new capture modalities emerge that current standards don't fully address.
This session explores the digitization of site operations and what it means for data interoperability. Key topics include:
1. Mapping disparate site data models to CDISC standards
2. Harmonizing terminology across distributed networks
3. Extending CDISC to support new data sources like ambient voice
4. Real-world use cases from inside pharma
The goal is open dialogue, identifying gaps, accelerating standards development, and inspiring collaboration toward faster, higher-quality data with less site burden.

Speakers

• HM

  Heather Marino

  Axtria Inc.

  Speaker

• JB

  Jim Box

  SAS

  Chair