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:
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
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.
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.
Business & Decision Life Sciences offers CDISC trainings organized through CDISC.
CDISC Registered SDTM & CDASH trainer for Europe & CDISC Registered Global Approach trainer for Europe
Business & Decision Life Sciences offers advice for companies looking for help on implementing CDISC standards.
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):
Strong Representation on the CDISC teams:
Past chair of the CDISC Advisory Board (CAB)