Biostatistics & Statistical Programming

CDISC Services

Today, CDISC standards are widely accepted by the industry and regulatory agencies.

Our team includes leading domain experts on the application of CDISC standards.

Our CDISC Services

Conversion of Legacy raw data into SDTM datasets

FDA Compliant Submission Data Packages – SDTM annotated CRF, define.xml

Analysis ready ADaM domains, ADaM define.xml

Validation documents and Open CDISC Report

Reviewer's Guide

SDTM/ADaM Compliant Integrated Databases