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.
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