CDISC

CDISC Standards

As CDISC authorized trainers in SDTM and ADaM, we provide expertise about requirements, processes, systems, as well as consultants experienced in implementing these standards.

We have advised several major pharmaceutical companies all the way from first steps of implementing CDISC through to full implementation. S-cubed’s consultants have converted over 100 studies to CDISC standards and supported more than 20 successful FDA submissions. Having worked with CDISC standards since 2004, we are very familiar with issues that typically arise and have unique insight about what works well.

The United States Food and Drug Administration recommends using CDISC (SDTM) standards for electronic submissions of all clinical data, and requires compliance with CDISC standards for all new clinical studies starting after December 2016. The European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency have also expressed intention to require CDISC.

 

 

Niels Both

Title: Data Standardisation and Implementation Specialist
Location: Denmark
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100+

studies as part of NDA submissions

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100%

accepted by the FDA

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OFFICIAL

CDISC Registered Solutions Provider

Registered Solutions Provider

CDISC-RSP.PNG

CDISC Registered Solutions Providers* (RSPs) are member organizations with CDISC expertise that provide products and services for specific standards

We are registered solution providers of the following CDISC standards:

  • Analysis Data Model (ADaM)
  • Clinical Data Acquisition Standards Harmonization (CDASH)
  • Controlled Terminology
  • Define-XML
  • Standard for Exchange of Nonclinical Data (SEND)
  • Study Data Tabulation Model (SDTM)

We are part of the official list of Registered Solution Providers at CDISC