Patient safety

China is looking to amend its GCP and bring more of the clinical trial industry up to speed

Amended Chinese GCP could aid development of CRO industry

By Zachary Brennan

The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part of efforts to further protect study subjects, experts say.

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...