CDISC Foundational Standards are the basis of the complete suite of standards, supporting clinical and non-clinical research processes from end to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.
Therapeutic Area (TA) Standards extend the Foundational Standards to represent data that pertains to specific disease areas. TA Standards include disease-specific metadata, examples and guidance on implementing CDISC standards.
CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
CST has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider. We have converted more than 20 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.
CST 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 at CST Team to deliver productivity improvements with in house data definition templates and in-house tool, used for mapping data to the SDTM format.
We are strong SAS Team to develop the macros, so it is an intended to do the data conversions easier than others. It minimizes 20% – 40% work would be reduced and faster delivery to the customers.
Additional we do
Also Provides CDISC Trainings to industry people.
Industry oriented CDISC SDTM and ADaM Training
We have well-defined SOP to data integrations and standardizations.
We provide defined data definitions and In-house macros, intended to give faster results with good quality.