CDISC | DMC | EDC
Clinical Data Interchange Standards Consortium (CDISC)
EMB associates are rooted and engaged in implementing Clinical Data Interchange Standards Consortium (CDISC) data standards for current and legacy data.
EMB benefits clients in many ways:
- As a gold member with active CDISC team representation, EMB is knowledgeable of past, present and future requirements and specifications.
- Detailed knowledge of CDASH, SDTM and ADaM standards; facilitating CDISC standards and terminology from protocol development through submission.
- Successful completion of numerous submission-ready projects for individual and integrated databases.
- Thorough understanding of how CDISC models impact submission strategies, as well as the drug development life cycle.
- Possess SDTM validation tools endorsed by the industry.
- Has the ability to create compliant Define.xml and Define.pdf documents, as well as all other required deliverables.
- Capable of guiding and optimizing a company’s effort during the period of transition to the FDA mandate.
- Able to provide 3rd party CDISC review prior to FDA submission.
EMB Statistical Solutions, LLC
55 Corporate Woods, 9300 West 110th Street, Suite 550, Overland Park, Kansas 66210