From Excel to Enterprise: A Sponsor’s Journey to Modern Clinical Metadata Management

As clinical development organizations expand their standards libraries and metadata assets, maintaining consistency, traceability, and governance across studies becomes increasingly challenging. Many organizations continue to rely on spreadsheets, manual processes, and fragmented workflows to manage standards, specifications, controlled terminology, and study metadata. Too often, the result is duplicated effort, limited reuse, and inconsistent implementation.

To address these challenges, organizations are increasingly adopting centralized metadata management strategies that bring standards, study metadata, and governance processes together within a single ecosystem.

Join Alnylam and Certara for a sponsor and partner perspective on the evolution from spreadsheet-based standards management to an enterprise Clinical Metadata Repository (CMDR) approach. Drawing upon real-world implementation experience, the speakers will discuss practical lessons learned in establishing metadata governance, improving traceability, supporting cross-functional collaboration, and enabling more consistent management of SDTM, ADaM, controlled terminology, EDC metadata, and study specifications.

The session will explore common challenges encountered during adoption, approaches for driving stakeholder engagement, and opportunities for improving efficiency through metadata-driven processes. Attendees will also gain insight into emerging trends and future opportunities for advancing end-to-end standards management across the clinical data lifecycle.