SCDM 2025 Annual Conference

Panel chair: Erin Erginer, Senior Director of Product

Panelists:

• Radhika Kale, Associate Director, Data Standards Statistical Programming, Alnylam Pharmaceuticals
• Chris Decker, President and CEO, CDISC

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 .CSV or form input to .XPT completely traceable for statistical programmers.
Our session chair, Erin Erginer, will guide a panel discussion, including 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.

Learning objectives

• The challenges experienced with traditional approaches to metadata management and standards governance
• How new standardization and governance strategies are transforming the clinical data workflow
• Hear the data standards and governance perspective from a top 5 pharmaceutical company, as well as insights on non-EDC data management from a top 10 biopharma

This session is designed for forward-thinking professionals ready to elevate their data governance infrastructure, to meet the challenges of clinical research.

The full list of panel attendees will be publicized in due course.

Presenter: Kristin Kelly | Senior Principal CDISC Consultant

Mapping source data to SDTM remains one of the most complex and time-consuming aspects of preparing for regulatory submission. Today’s clinical studies draw from a wide array of data sources, leading to greater data variety and complexity. At the same time, strict adherence to CDISC SDTM standards is required for successful submissions to regulatory authorities like the FDA and PMDA.

Traditionally, SDTM specification mapping has been managed in spreadsheets—a manual, error-prone process that often slows down timelines and jeopardizes data quality. But there’s a more efficient way forward.

Presenter: Julie Ann Hood | Principal CDISC Consultant

Pinnacle 21 has long been recognized as the gold standard for ensuring submission compliance of standardized study datasets. But what if compliance issues could be prevented before they ever occur? That’s the vision behind the new Pinnacle 21 Metadata Repository (MDR).

The MDR provides a centralized, standards-driven environment where teams can design forms, manage controlled terminology, govern standards, validate incoming datasets from vendor data, and generate mapping specifications, all within a streamlined workflow. By consolidating these critical activities, the MDR reduces reliance on fragmented spreadsheets and manual processes that often slow studies down and introduce inconsistencies.

The result is a more efficient, connected process that ensures metadata is consistent, reusable, and compliant at every stage. From protocol design through submission, the Pinnacle 21 Metadata Repository empowers organizations to work faster, minimize rework, and improve confidence in the quality of their deliverables. With fewer errors, shortened timelines, and end-to-end traceability, it transforms metadata management from a reactive task into a proactive driver of quality and regulatory success.

By shifting to a collaborative, purpose-built environment like Pinnacle 21, teams can define SDTM mapping specs once and reuse them across studies—dramatically improving speed, accuracy, and compliance.