GVK accused of tampering with data in Indian clinical trials – FierceCRO

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.

Read more – FierceCRO