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.  

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