Elevating the Investigator Site File: Driving Standardization and Data Integrity in Global Clinical Trials

About this session

Part of Session 3, Track E: Site, Sponsor & Service Provider Partnerships (Chair: Sarah Dean, Precision for Medicine).

While clinical data and TMF processes have seen increasing levels of standardization, the Investigator Site File remains a largely overlooked component of trial operations. Often managed through fragmented systems and inconsistent processes, ISF practices limit traceability, reduce efficiency, and introduce compliance risks across global studies.
This presentation explores how a more structured, standardized approach to ISF management can enhance data integrity and operational performance. By applying principles aligned with CDISC standards, such as consistent metadata, harmonized document structures, and improved process integration, combined with AI for document classification and automated metadata mapping with sponsor eTMF systems, organizations can strengthen inspection readiness and enable better collaboration between sponsors, CROs, and sites.
Through practical examples, including regional expectations, we illustrate how modernizing ISF practices supports scalability while maintaining local adaptability. Attendees will gain insights into how elevating the ISF with intelligent automation contributes to more efficient, connected, and compliant clinical trial execution.

Speakers

• GG

  Guillaume Gerard

  Agatha

  Speaker

• SD

  Sarah Dean

  Precision for Medicine

  Chair