CDISC

clinical_data_standards_CDISCCDISC Mapping

CROS NT is a CDISC Gold Member, meaning it has constant access to new data standards and new documentation regarding CDISC standards. CROS NT has helped many companies incorporate CDASH, SDTM and ADaM standards into their organizations and mapped legacy studies to create the necessary consistency in formats. Our statistical programming team has developed excellent macros to reduce time, costs and ensure consistency.

CDISC Consultancy and Services:

  • Creation of related documentation: SDTM annotated CRF, SDTM metadata, DEFINE.PDF, DEFINE.XML
  • Creation of documentation related to ADaM: analysis level, dataset level, variable level, parameter level documentation
  • Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and regulatory submissions
  • Creation of documentation for integrated databases
  • Statistical programming of Tables, Figures and Listings using ADaM derived datasets as input for the production of statistical results

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Resources

CDISC Standards and Breast Cancer Studies
Using CDISC to Ensure Traceability for Regulatory Authority Submissions
CDISC Mapping: How to Standardize Clinical Data While Controlling Costs
FDA Data Standards for Regulatory Submissions: are your datasets CDISC compliant?