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.”