From Complexity to Clarity: Simplifying SDTM Mapping for Faster, Compliant Submissions
Information
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.
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.
