CDISC Expert to help build a Tech Product

I’m ready to roll out ADaM for an ongoing clinical study and need an experienced CDISC specialist to take the lead on standards implementation. The SDTM package is already complete, yet I’d like a fresh, expert review to be sure it aligns with the latest CDISC/FDA expectations before submission.

Your main focus will be building the full ADaM layer—starting from detailed specifications through to validated datasets—while also performing a targeted quality check on the existing SDTM deliverables. Expect to work with SAS, Pinnacle 21, and define.xml 2.1 as part of the workflow.

Deliverables I need from you:
• Comprehensive ADaM specification document with clear derivations and terminology references
• Production-ready ADaM datasets (.xpt and .sas7bdat) fully validated in Pinnacle 21
• define.xml (v2.1) and reviewer’s guide linked to both SDTM and ADaM metadata
• Independent QC report summarising SDTM findings and the final ADaM validation logs

Acceptance criteria: All Pinnacle 21 issues at “None” or “Acceptable,” and any SDTM findings clearly documented with resolutions.

If you have a solid track record of implementing ADaM and polishing SDTM for regulatory submission, I’d love to hear how quickly you can start.