Biogen Transforms Study Metadata Management with Certara’s Metadata Repository

Prior to working with Certara, Biogen faced challenges in clinical trial metadata management:

• Decentralized processes: Maintaining clinical data standards, such as CDASH, SDTM, and ADaM, in Excel spreadsheets was inefficient and labor-intensive.
• Version control issues: Spreadsheets made it harder to track changes, manage legacy content, or enable effective content reuse.
• Scalability limitations: Managing clinical trial metadata in spreadsheets meant that it was hard to scale as the number of studies grew.

To address these challenges, Biogen adopted the CRF Creator module (formerly known as Formedix ryze) within the Pinnacle 21 Enterprise (P21E) platform, together with a clinical metadata repository solution and standards governance solution.

Key Implementation Highlights:

• Centralized Metadata Repository (MDR): P21E provided Biogen with a single source of truth for managing clinical trial metadata, enabling easy access, searchability, and reuse of content across studies.
• Enhanced Traceability: The platform allowed Biogen to track changes in metadata across versions, ensuring robust audit trails and traceability of metadata for regulatory compliance.
• Standards Management: Biogen developed strong controlled terminology, and CDASH metadata standards using the platform.
• Efficient Content Reuse: Metadata from past studies could be visualized, repurposed, and refined for future use, reducing duplication of effort in creating forms.

By leveraging the Pinnacle 21 Enterprise platform, Biogen saw improvements across its study metadata management workflows.

Outcomes at a Glance:

• Higher Reuse Rates: A vast repository of standardized metadata now allows for streamlined content reuse and visualizations of changes, driving efficiency across 100+ global studies built in Rave.
• Improved Standards Compliance: Frequent updates to standards are now managed seamlessly, ensuring consistency with CDISC standards.
• Optimized Workflows: The process of reviewing and upgrading ADaM content has improved, enabling Biogen to transition from ADaMIG v1.1 to v1.3 faster and more effectively than using spreadsheets.

Biogen’s adoption of the Pinnacle 21 Enterprise platform has set a new standard for efficiency in their clinical metadata management. By transitioning from siloed and manual processes to an integrated metadata repository, Biogen has streamlined study builds, ensured regulatory compliance, and positioned itself for future scalability.