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