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Statsmetrika 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.

Statsmetrika has an expert team of with strong technical understanding of both Study Data Tabulation Model (SDTM) anlysis Data Model (ADaM), corresponding implementation and Reviewers’ guides, CDISC terminologies and the related regulations.

We have used our product development expertise to deliver productivity improvements with TMetrika , 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.

We are CDISC solution providers of the following CDISC standards:

  • Analysis Data Model (ADaM)
  • Clinical Data Acquisition Standards Harmonization (CDASH)
  • Controlled Terminology
  • Define-XML
  • Standard for Exchange of Nonclinical Data (SEND)
  • Study Data Tabulation Model (SDTM)