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Clinical Trial Events
SCDM 2025 Annual Conference

Panel Clinical Data Competencies & Cross-Functional Interactions · Technology & Data Platforms · Regulations & Standards · Clinical Trial Operations

Metadata for All: Applying Standardization Across the End-to-End Data Pipeline

Sun, Sep 28, 2025 · 11:30 AM–12:30 PM EDT Room 337+338, Baltimore Convention Center

About this session

Session chaired by Erin Erginer
Description:
Who can benefit from well governed metadata?
The answer is broader than you might imagine. In this session we will discuss metadata management best practices across eCRF design, EDC build, vendor data transfers, and creation of submission datasets - including SEND, SDTM and ADaM.
A single source of truth for your metadata ensures consistency across studies and standards, whilst making the path from source data to deliverable completely traceable for statistical programmers.
Our session chair, Erin Erginer, will guide a panel discussion around strategies for standardization - from the point of data collection to submission. The panel will consider the approach of ‘designing with the end in mind’ for expedited data analysis and submission.

Speakers

  • Erin Erginer

    Vice President of Product · Certara

    Speaker

  • Chris Decker

    President & CEO · CDISC

    Speaker

  • Lisbeth Bregnhøj

    Senior GCP Inspector · The Danish Medicines Agency

    Speaker

  • Radhika Kale

    Associate Director, Data Standards Statistical Programming · Alnylam Pharmaceuticals

    Speaker

  • Vrinda Gopalmenon

    Associate Director · Merck

    Speaker

  • Fred Bermont

    Director, Clinical Data Standards and Integration · Moderna

    Speaker