Patient safety

Review finds falsified electrocardiograms by 10 different employees at GVK

Update

EMA opens investigation into India’s GVK Bio over ECG falsifications

By Zachary Brennan

At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated. 

French regulator raises concerns over Indian CRO studies

French regulator raises concerns over Indian CRO studies

By Zachary Brennan

Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...

Concerns raised over FDA’s informed consent draft guidance

Concerns raised over FDA’s informed consent draft guidance

By Zachary Brennan

The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.

CDSCO issues raft of new trial regulations

CDSCO issues raft of new trial regulations

By Gareth MACDONALD

Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.