What factors should we consider when selecting a contract research organization (CRO) for CDISC work?
Selecting the right CRO to handle your CDISC work can be a daunting task. As you evaluate potential partners, it’s critical that you consider factors beyond whether or not they have a CDISC certification. This list provides 10 criteria that can help you make an informed decision about which CRO is right for your CDISC project or program. A successful CRO should: • Have experience mapping and programming clinical data to SDTM for individual studies, for an entire submission, and for legacy conversions. • Demonstrate an understanding of the validation requirements for SDTM data and the define files and should have validation tools endorsed by FDA. • Be able to explain how metadata requirements drive SDTM programming efforts. • Have tools that create efficiencies across multiple studies. • Express familiarity with XML and related technologies. • Have tools to produce a CDISC compliant define.xml file as well as other CDISC deliverables. • Understand how to integrate SDTM and analysis work
Related Questions
- We have been disappointed in the results produced by our current contract research organization (CRO) and may transition the study to another CRO. How can we make the transition as smooth as possible?
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