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CDISC

CDISC has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

CDISC data format has become a standard in the Pharma Industry for data format and data structure in data management and biostatistics.   This allows companies to use a standard flexible and adaptative data models across all therapeutic areas.

CDISC format is now required for submissions by Food and Drug Administration (FDA).

4Clinics, member of CDISC, can help you in:

  • remap your existing databases in CDISC format for submissions
  • remap your existing databases in CDISC format for ISS and ISE
  • migrating from your existing database format in CDISC format on your existing systems
  • validating and documenting the migration from your existing data structure to CDISC format structure
  • reanalyzing your data and comparing the results after migration with previous results
  • training and supporting your teams during migration to CDISC format
  • advicing and supporting your teams during migration and remapping projects

 

4Clinics uses CDISC as a standard for its database structure.  Our collaborators have been trained on CDISC in Data Management and Biostatistics and we helped various Pharma companies in CDISC remapping. 

4Clinics is member of CDISC since 2007.

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