In a rare move, the FDA has informed sponsors that used two Indian CROs with concerning data integrity practices that some studies those firms conducted will need to be repeated.

The FDA issued a public warning that it will not accept bioequivalence or bioavailability studies conducted by Synchron Research Services or Panexcell Clinical Lab, two Indian CROs that the agency identified as having troubling data integrity problems. The pair of companies have been around since 1998.

This sort of action against CROs is something rarely seen from the FDA; the last occurrence was in April 2016 and involved another Indian CRO, Semler Research.

An FDA review is currently underway to root out any potential safety issues and none have been identified thus far. The agency’s probes in this most recent case revealed significant instances of misconduct and regulatory violations that rendered the study data they submitted invalid. But also worrying is that the FDA took this long to take action against the CROs. The agency issued both firms untitled letters in 2019, outlining “significant objectionable conditions” it found during November 2019 inspections. “We do not make decisions lightly and do not rush to judgment,” an FDA spokesperson said in defending the two-year lag.

Both Panexcell’s and Synchron’s untitled letters describe “unusual and unexplainable study records” linked to concerning approaches that impacted the firms’ analytical methods. After review, the FDA determined that the study data the two companies submitted were falsified and unreliable. The names of the studies and sponsors affected by the data integrity problems were redacted from the letters.

Read the Panexcell letter here: https://bit.ly/3D2QJxZ.

Read the Synchron letter here: https://bit.ly/3F9bV7j.