CDISC Services

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Submissions of New Drug Applications (NDAs) to the FDA, require to submit clinical study data according to the CDISC standards.

Business & Decision Life Sciences provides a number of expert CDISC services and tailored solutions, including:

CDISC Data Conversion

CDISC data conversion – SDTM and AdaM

  • Regulatory submission preparation
  • CDISC legacy data conversion

Implementation of CDISC standards

Implementation of CDISC standards in the sponsor’s biometrics environment

Business & Decision Life Sciences offers CDISC Implementation services tailored for your company and platform independent

CDISC compliance checking

The Data Model Compliance Checker (DMCC) verifies your studies against the current CDISC standards, such as SDTM, ADaM, controlled terminology (CT) and define.xml, or your own proprietary standards.

Generation of Define.xml

Define-it reads metadata specifications and mapping definitions of the SDTM standards and the available CDISC controlled terminology (CT) and produces compliant Define.xml files available for your FDA submission or internal use.

CDISC training

Business & Decision Life Sciences offers CDISC trainings organized through CDISC.

 

CDISC Registered SDTM & CDASH trainer for Europe & CDISC Registered Global Approach trainer for Europe


CDISC Roadmap

Business & Decision Life Sciences offers advice for companies looking for help on implementing CDISC standards.


 

CDISC Expertise and Strengths

Business & Decision Life Sciences is a recognized expert in the CDISC field and is:

CDISC Registered Solution Provider

Chair of the European CDISC Coordinating Committee (E3C):

  • official representation of CDISC in Europe (EMA, IMI, SDOs, …)
  • responsible for organizing the European CDISC Interchange

Strong Representation on the CDISC teams:

  • 2 SDTM team members
  • 1 CDASH team member
  • 1 Controlled Terminology team member

Past chair of the CDISC Advisory Board (CAB) 

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