Cytel has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider. We have converted more than 150 studies as part of NDA submissions, all of which have been accepted by the FDA. 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.
Cytel has an expert team with strong technical understanding of both Study Data Tabulation Model (SDTM) analysis Data Model (ADaM), corresponding implementation and Reviewer's guides, CDISC terminologies and the related regulations.
We have used our product development expertise to deliver productivity improvements with MapGenie™, an in-house tool, used for mapping data to the SDTM format.
The combination of efficient technology, and a global team of trained and experienced resources enables us to deliver high-quality datasets at a cost saving of 20% to 40% compared with traditional service providers.