Data Standards Implementation

CDISC data standards are rapidly becoming industry standard and are required for most FDA submissions. These standards are now adopted in various phases of clinical research. With our experience and ability to stay up to date with current technologies we can help your company make data standards implementation and migration seamless.

CDISC Standards

Veristat is an active member of the Clinical Data Interchange Standards Consortium (CDISC) and an approved Registered Solutions Provider.  We currently follow STDMIG 3.1.3 to STDMIG 3.2 and ADaMIG 1.0. As an industry leader we continuously discuss trends and changes to the implementation guidelines with CDISC to ensure we stay up-to-date with CDISC standards as they come available.
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Explore Our Standards Implementation Services

  • CDISC Compliant Case Report Forms Gap Analysis of Study Documents and Data
  • CDASH Annotated Case Report Forms
  • SDTM Annotated Case Report Forms
  • Trial Design Compliant Datasets
  • SDTM Compliant Datasets
  • ADaM Compliant Datasets Compliant Datasets
  • Integration of Controlled Terminology (CDISC and Sponsor-Defined)
  • Generation of Define.xml and Reviewer’s Guide
  • ADaM Metadata
  • Utilization of OpenCDISC (Pinnacle 21)
  • Comprehensive Quality Control Measures
  • Strategic Consulting

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