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CDISC expertise and consultancy from SGS, an official CDISC Registered Solution Provider.

Clinic biometrics

Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) provide a standard structure for organizing and formatting clinical data. We offer you extensive CDISC expertise and consultancy with highly qualified and experienced CDISC members across biometrics teams. For many years, we have used the SDTM and ADaM structure, and all trials are processed using CDISC standards. Our complete compliance with CDISC results in efficiency, time saving, process improvement, reduced time for regulatory submissions and better communication among team members without delays in reporting final data.

Why choose SGS CDISC expertise and consultancy?

We are qualified as an official CDISC Registered Solutions Provider (RSP) for the following standards:

  • SDTM
  • ADaM
  • Define.xml

We provide you with:

  • Extensive CDISC knowledge on therapeutic-specific domains
  • Our own implementation guide (IG) for SDTM in the absence of your own SDTM IG
  • Extensive experience with client-defined SDTM requirements, ensuring reduced client quality control and timely delivery of high-quality standards
  • Support towards the development and maintenance of client CDISC implementation guides for SDTM, ADaM and Define.xml
  • SDTM datasets shortly after FPI supporting your ongoing data evaluation at an early stage in your trial
  • A metadata repository or automated completion of Define.xml by in-house developed applications, reducing manual operations to a minimum and resulting in more accurate Define.xml
  • Tailored legacy database solutions, according to your needs

Comprehensive CDISC expertise and consultancy from a world leader 

We offer you unrivaled experience in CDISC expertise and consultancy. We continue to expand our in-depth CDISC knowledge and experience and, to date, have:

  • Reached CDISC Platinum membership
  • Become a member of the CDISC Advisory Board
  • Developed our own in-house validated software to ensure CDISC compliance and Principle of Harmonization
  • Devoted CDISC registered Define.xml / Dataset.xml trainers 
  • Become a member in the ADaM PK sub-team working on the development of ADaM guidance for PK analysis
  • Implemented CDISC ADaM in the pharmacokinetics department
  • Successfully supported multiple FDA submissions
  • Implemented end-to-end CDASH-SDTM-ADaM
  • Trained employees on the Standard for the Exchange of Nonclinical Data (SEND)

To discuss how you could benefit from our CDISC expertise and consultancy, contact us today.