Sessions:
July 15, 2025 – 11am ET
July 17, 2025 – 11am IST
Services: Biostatistics & Statistical Programming
Products: Pinnacle 21
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
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Senior Product Manager, Certara Pinnacle 21
Amy is a Senior Product Manager at Certara, specializing in advanced solutions and metadata repositories (MDR). With over a decade of experience in CDISC standards and clinical data operations, she is passionate about creating practical, efficient solutions that empower clinical programmers.
Customer Success Manager, Certara Pinnacle 21
Gilbert joined Formedix, now part of Certara, nearly ten years ago as a technical writer. The system knowledge he gained from content development, together with his existing customer service skills, marked him out for transition to the Professional Services (PS) team.
Gilbert has worked with the PS team for over four years, providing both CDISC-based training and software training, as well as support and consultancy services to Pharmaceutical, Biotechnology and Clinical Research Organizations. He helps organizations build studies faster and to a higher quality by making their clinical trial design and regulatory submissions far more efficient.
Today, as Customer Success Manager, Gilbert’s focus is to ensure customers maximize the benefits they can achieve by overcoming their challenges and achieving their goals.
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