Services
Statistical Programming
Validated, submission-ready datasets and outputs built to meet the expectations of global regulatory agencies.
Our statistical programming team transforms clinical data into validated, submission-ready datasets and outputs. We work across SAS and R to deliver CDISC-compliant data packages that meet the expectations of the FDA, EMA, NMPA, and TGA.
Core Capabilities
SDTM and ADaM Dataset Development
We map raw clinical data to Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards, maintaining full traceability from source to submission.
Tables, Listings, and Figures
Our programmers produce validated TLFs for Clinical Study Reports, interim analyses, and regulatory briefing documents. Every output goes through independent double programming or QC review.
Define.xml and Reviewer's Guides
We prepare complete define.xml files and Reviewer's Guides for eCTD submissions, making it easy for regulatory reviewers to navigate your data package.
Integrated Submission Packages
For programs with multiple studies, we create Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) datasets and outputs, pooling data across trials for a complete regulatory picture.
Legacy Data Conversion
If your program includes older studies with non-CDISC data, we handle the conversion to current standards so your entire submission package is consistent and compliant.