From Repository to Intelligent Platform: Connected Standards and AI for RWE eTMF

About this session

Part of Session 5, Track E: TMF Interoperability (Chair: Karen Roy, CDISC).

Real-world evidence studies expose the limits of trial-centric eTMF models: manual filing, inconsistent metadata, weak traceability, and fragmented system handoffs. This presentation explores how a connected, product-driven approach can modernize TMF management for RWE. We will demonstrate how TMF standards, RWE-specific document frameworks, interoperable APIs, and FHIR-aligned data exchange can enable smarter configuration of expected content from study startup through inspection readiness. We will also examine practical AI use cases, including automated artifact classification, metadata recommendation, completeness forecasting, anomaly detection, and continuous quality monitoring, with human oversight built in. Attendees will leave with a blueprint for transforming eTMF from a document repository into an intelligent, interoperable platform that reduces operational burden, improves compliance, and scales with the future of digital clinical research.

Speakers

• TS

  Thomas Stonehouse

  Oracle

  Speaker

• CH

  Chris Huang

  Oracle

  Speaker