CDISC Compliance Solutions
End-to-end CDISC standards implementation for clinical data submissions.
SDTM
& ADaM
FDA
Ready
100%
Compliance Rate
Overview
Navigating CDISC standards is essential for any clinical data submission to the FDA or EMA. Our CDISC compliance team helps sponsors and CROs map raw clinical data to SDTM and ADaM formats, create define.xml documentation, and generate submission-ready datasets that pass OpenCDISC validation without rework.
Features & Capabilities
SDTM Mapping
Raw data to Study Data Tabulation Model with full traceability.
ADaM Datasets
Analysis-ready datasets compliant with CDISC ADaM standards.
Define.xml
Machine-readable metadata documentation for regulatory submissions.
Validation
Pinnacle 21 (OpenCDISC) validation with issue resolution.
How It Works
Data Review
Assess source data structure and create SDTM mapping specifications.
Conversion
Transform data, build datasets, and generate define.xml.
Validation
Run Pinnacle 21 checks, resolve issues, and certify submission readiness.
What Sets Us Apart
- Experienced across therapeutic areas (oncology, CNS, rare disease)
- Pinnacle 21 zero-error track record
- Support for both SEND (nonclinical) and SDTM (clinical)
- Post-submission amendment support
Ready to Get Started?
Tell us about your project and we'll respond within one business day.
