Selecting 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:
- 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 to meet your deadlines.
- Have completed multiple submissions to FDA.
- Have a technical acceptance rate of more than 90%.
- 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?