CDISC Data Standards Implementation

CDISC data standards have become the industry standard and are required for clinical trial data included in FDA submissions. These standards are now adopted in all 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, even though it can be a complicated process.

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.

As you start planning your regulatory submission for the FDA, you should consider implementing standard data collection tools to meet the expectations of the regulatory agency for standardized data in your submission.   You may be required  to convert data for legacy studies.   

We will help you determine the “ideal” approach for your regulatory submission, outlining the risks and benefits to differing strategies.   If you have a data standards implementation strategy in place, our experts can help you execute your data conversions.

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Our Data Standards Implementation Team Provides

  • CDISC Compliant Case Report Forms Gap Analysis of Study Documents and Data
  • CDASH Annotated Case Report Forms
  • Study Data Tabulation Model (SDTM) Annotated Case Report Forms
  • Trial Design Compliant Datasets
  • SDTM Compliant Datasets
  •  Analysis Data Model ( ADaM) 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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