Clinical Trial Operations
Regulatory and Drug Development Consulting
Government and Public Health Services
Biometrics
Clinical Pharmacology Modeling SimulationOur team has CDISC expertise and can set up a CDISC strategy that fits corporate, financial, and regulatory goals. We have created CDISC, SDTM, and ADaM–compliant datasets for over 60 studies and have performed many CDISC-compliant regulatory submissions. Our experience includes:
- Ongoing studies, historical databases, and legacy conversions
- Programming specifications for SDTM and ADaM
- SDTM and ADaM domains (SAS datasets/transport files)
- SDTM annotated CRF (acrf.pdf)
- Define.xml files for SDTM and ADaM
- Reviewer’s guides in multiple formats (e.g., PHUSE standard) including validation confirmation and Pinnacle 21 notes
- Study program guides that provide details on how programs and macros are used to create the SDTM and ADaM domains