CDISC Services

The Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities including the FDA.

Our team has a strong technical understanding of both Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM), corresponding implementation and Reviewer's guides, CDISC terminologies and the related regulations. The combination of efficient technology, and an expert team of trained and experienced resources enables us to deliver high-quality datasets at a cost saving compared to traditional service providers.

CDISC Deliverables

We provide consultancy and support in your data migration processes from Raw to CDISC standards as well as client specific standards.

Preparation of SDTM Annotated CRF

CDISC SDTM migration

CDISC ADaM derivation

Define.xml creation

Mapping Process Automation

We can assist you in completely automating your existing mapping processes using simple and cost-effective tools and techniques.


CDISC ADaM Derivations

SAS Macro library setup