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CDISC Compliance Expertise

Tech Observer has extensive experience in helping its customers become CDISC compliant. We have worked on large and small CDISC specific projects, some involving only consultancy and others involving mapping of multiple studies to CDISC standards.

Our services include:
  • Creation of customized CDISC solutions

  • Building new CDISC SDTM compliant databases

  • Creation of CDISC SDTM domains from various customer-defined data standards

  • Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission

  • Converting CDISC ODM XML to SAS® datasets and vice versa

  • Creation of the 'Case Report Tabulation Data Definition Specification', (DEFINE.XML) for submission to the FDA

  • Statistical programming using ADaM derived datasets as inputs to the SAS® report code

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