Mapping source data to SDTM is one of the most challenging elements of submission readiness. The average study, now comprised of seven different data sources, contains increasingly varied and complex data, and compliance with CDISC SDTM standards is non-negotiable for regulatory submissions to the FDA and PMDA.

Traditionally done via spreadsheets, mapping SDTM specs has been a slow and error-prone process that delays analysis and submission. Now there’s a better way, built on the principle of “define once and reuse again and again”.

Ditch the spreadsheets and see how creating and managing your SDTM mapping specs in a collaborative, purpose-built workspace can deliver the speed, quality, and compliance needed for successful submission.

Key takeaways:

• Limitations of traditional approaches to SDTM mapping
  • Typical drawbacks of using Excel for mapping specs
  • Challenges of using proprietary low-code web-based tools for mapping specs
• The need for metadata-driven programming
• The why and how of cross-study reuse
  • Standards
  • Mapping specs
  • Reference data
• Keys to getting metadata content into your statistical computing environment
• The importance of traceability

Speakers:

• Amy Garrett, Senior Product Manager, Certara Pinnacle 21
• Gilbert Hunter, Customer Success Manager, Certara Pinnacle 21