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CDISC / eSubmission

Ensuring 100% CDISC Compliance for Your Data

ClinChoice raises the standard of excellence in clinical data by ensuring your data is 100% CDISC compliant and fully validated, all within your timelines and budget. We know the value of standardized study data pertaining to Clinical Data Interchange Standards Consortium (CDISC) specifications. We’re proud to be a CDISC Registered Solutions Provider and have worked with the organization since 2002. We skillfully employ all CDISC standards and remain current with FDA submission guidance and expedite implementation to promote efficient agency review.

In the past five years, we’ve prepared more than 1000 SDTM / ADaM study packages across 75 compounds for 20 companies. We’ve created SDTM / ADaM for ISS / ISE packages for with expansive projects, including up to 38 protocols from Phase I to III, conducted throughout the US, Europe, and Asia.

Our CDISC Implementation & eSubmission Services

Process Improvement & CDISC SDTM / ADaM Implementation Consulting

  • Develop company standards based on CDISC current models
  • Optimize data flow from data capture CDASH to SDTM to ADaM to TLFs
  • Optimize clinical toolsets to achieve standards and return on investment
  • Knowledge transfer of data standardization process
  • Study data standardization plan (SDSP)

 

Legacy & Ongoing Study Data Conversions to SDTM Standards

  • SDTM annotated CRF (aCRF.pdf)
  • SDTM mapping specifications
  • Conversion of legacy raw datasets to SDTM datasets
  • SDTM define.xml
  • SDTM compliance checks using OpenCDISC / Pinnacle 21 Validator
  • SDTM Reviewer’s Guide (SDRG)

 

ADaM Standards

  • ADaM specifications
  • Creation of ADaM datasets
  • ADaM define.xml
  • ADaM compliance checks using OpenCDISC / Pinnacle 21 Validator
  • ADaM reviewer’s guide (ADRG)

 

Extensive SDTM / ADaM Experience Since 2002

  • CDISC Gold Member
  • CDISC Registered Solution Provider
  • Co-leader of a CDISC / FDA Data Integration Pilot
  • Member of CDISC SDS Working Group
  • Member of CDISC ADaM Working Group
  • Member of CDISC XML-Tech Group
  • Member of CDISC China Committee