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10 Tips for Choosing a Contract Research Organization for CDISC Work

Posted by Brook White on Thu, Jun 14, 2012 @ 09:53 AM

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contract research organization (CRO) for CDISC workSelecting the right contract research organization (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 contract research organization should:

  1. Have experience mapping and programming clinical data to SDTM for individual studies, for an entire submission, and for legacy conversions.
  2. Demonstrate an understanding of the validation requirements for SDTM data and the define files and should have validation tools endorsed by FDA.
  3. Be able to explain how metadata requirements drive SDTM programming efforts.
  4. Have tools that create efficiencies across multiple studies.
  5. Express familiarity with XML and related technologies.
  6. Have tools to produce a CDISC compliant define.xml file as well as other CDISC deliverables.
  7. Understand how to integrate SDTM and analysis work to meet your deadlines.
  8. Have completed multiple submissions to FDA.
  9. Have a technical acceptance rate of more than 90%.
  10. Demonstrate an understanding of how CDISC models fit into the life cycle of a drug development project and how CDISC standards fit into a regulatory submissions strategy.

If you are already using a contract research organization for CDISC services, what criteria did you consider?

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