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Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner

Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner


In September 2021, the FDA issued a notification to the biopharmaceutical industry alerting them that multiple clinical studies conducted by two India-based CROs were “not acceptable” because of data integrity concerns.


Following inspections conducted in 2019 at the CROs’ facilities in India, as well as analyses of study data generated by them, which were used in “several applications,” the FDA determined that data from the two CROs are “not acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic products are bioequivalent to brand name products.” In fact, the FDA asked sponsors that conducted trials at the two India-based CROs to redo bioequivalence/bioavailability studies essential for regulatory approval, noting that the action is part of the FDA’s “continued vigilance and commitment to data integrity and protecting consumers from products that may put them at risk.”


How can sponsors avoid such situations when selecting and partnering with CROs?


Here are five things to keep in mind:


  1. Don’t compromise on data quality. While data management is critical to clinical trials and successful FDA submissions, CRO services can be cost and time intensive and, as a result, some sponsors look for alternatives, which all too often only create more problems. There’s a reason why the phrase “you get what you pay for” is still relevant today.
  2. Expertise, expertise, expertise. When looking for your next CRO partner, do your research. Identify high-quality hubs for CRO professional services, interview different providers who have a reputation for being experts in the field and ask for references. You wouldn’t let your car mechanic pull your tooth, so why would you compromise on who is managing your clinical trial data?
  3. Trust your instincts. Are you overwhelmingly satisfied or just content? You chose your CRO partner for a reason – because you trust them to work as hard as you do. If you’re not completely satisfied, explore why and what can be done to improve the partnership.
  4. The “valley of death” is real. It’s probably safe to say that the sponsors who used the two CROs cited in the recent FDA notification are thinking a lot about their next steps and seriously regretting previous ones. Switching CROs will incur more time and costs, on top of the significant investments those sponsors have already lost.
  5. Easy and exceptionally fast data management is a myth. Any experienced data manager will tell you that quality is the highest priority. If data management is being sold as easy or fast, that should be a major red flag. Take your time choosing a CRO partner. If you need another CRO to rescue your study, then you’ve already lost.


In summary, a robust and thorough CRO qualification process is essential. When selecting your CRO partners, take the time to ensure they truly are experts in their fields.


Read more on our Forum for EmergingBio’s Outsourcing Decisions.

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