Fudged ECG Reports: GVK Blunder Or All Just Over Blown?
This article was originally published in PharmAsia News
Executive Summary
GVK Biosciences, the Indian contract research organization (CRO) which has been under the glare of European regulatory agencies on charges of data manipulation, claims it followed standard operating procedures and that it cannot be faulted for check-out ECG readings of healthy volunteers that were found to be “similar” in nine studies.