Indian CRO GVK Biosciences is working to get back in the good graces of European regulators after inspectors found evidence that its employees doctored clinical trial results.
As India's Financial Express reports, in May investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad clinical outpost and discovered that the CRO's workers repeatedly switched out patient ECG scores with those of healthy volunteers.
Now Europe's Coordination Group for Mutual Recognition and Decentralized Procedures-Human is working to identify which drugs, approved or pending, might have been affected by the issue, according to the FE.
For its part, GVK says it has met with regulators, submitted detailed corrective plans and received the green light to move ahead.
"We are in the resolution stage and hope to close the matter to their satisfaction at the earliest," CEO Manni Kantipudi told the newspaper.
The issue could be a significant setback for GVK, which has been expanding its operations throughout and beyond India over the past year. The fast-expanding CRO has quickly transitioned from a local player into an international force, making its way into the U.S. through a buyout of California's Aragen Bioscience earlier this year. Among the CRO's clients are Astellas, Bayer, Endo Health Solutions ($ENDP), Onconova ($ONTX) and the FDA.
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