Biogen Transforms Study Metadata Management with Certara's Metadata Repository

After bringing data management in-house from a CRO in 2019, Biogen relied heavily on spreadsheets to maintain CDASH, SDTM, and ADaM standards, creating version-control problems, hindering content reuse, and limiting scalability as its study count grew. Biogen adopted Certara's Pinnacle 21 Enterprise platform, specifically the CRF Creator module combined with a centralized clinical metadata repository and standards-governance solution, giving it a single source of truth for metadata across studies. The platform supported 100+ global studies built in Biogen's EDC system (Rave), improved the review/upgrade of ADaM content (enabling faster transition from ADaMIG v1.1 to v1.3), and achieved higher reuse rates through standardized visualizations. Todd Bazin, Biogen's Head of Data Standards, said: "The platform is our authoritative source for metadata...we can ensure that our global library accurately reflects our standards."

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.