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CDISC Factory


Centreum’s CDISC factory supports and accelerates the set-up of CDISC compliant systems and conversions of legacy clinical trial data to the CDISC standards. By implementing Centreum’s service delivery lifecycle we can support your CDISC conversion requirements from insourcing key activities to outsourcing complete dedicated projects. Our consultants and virtual team at the client site can aid in the conversion process of legacy data at any stage in any role.


CDASH – Clinical Data Acquisition Standards Harmonization
  • Creation of customized CDISC solutions
  • Implement CDASH in DBMS
  • A tool to automatically convert CDASH compliant raw datasets into SDTM
  • Rollout SDTM from the database at the push of a button


SDTM - Study Data Tabulation Model
  • Generic mapping application
  • Metadata-driven approach
  • Tools to automatically annotate blank CRFs
  • Global macro library
  • SDTM Define.xml generator
  • A tool to automatically create SDRG (Study data reviewer’s guide)
  • SDTM validation tool
  • A tool to compare metadata across different trials
  • A tool to compare metadata across different trials
  • Use the OpenCDISC validator enhanced with additional FDA validation rules to validate all outputs against SDTM standards


ADaM - Analysis Data Model
  • Metadata-driven approach
  • Implement custom macros in a standard and validated way
  • ADaM Define.xml generator
  • A tool to automatically create ADRG (Analysis data reviewer’s guide)
  • ADaM validation tool
  • Template based reporting system for creating Tables, Listings & Figures (TLFs)
  • Complete control over the layout of TLFs
  • A tool to compare metadata across different trials
  • A tool to compare outputs across submissions


ODM - Operational Data Model
  • Tool to import CDISC ODM XML format into SAS
  • Tools to create SDTM & ADaM Define.xml
  • Tools to create SDTM & ADaM Define.pdf
  • Tool to read Define.xml for metadata validation


SEND - Standard for Exchange of Nonclinical Data
  • SEND Standardized datasets in XPT format
  • Define.xml and Define.pdf files compliant with CDISC specifications
  • Use OpenCDISC validator enhanced with additional FDA validation rules to validate all outputs against SEND standards
  • Compilation of a SEND Reviewer’s Guide, considered by the FDA to be an “integral part of a standards-compliant study data submission”