WHO Says Indian Company Mishandles Clinical Trial Records

July 8, 2015

According to a Wall Street Journal article, a CRO in India is being scolded for its handling of clinical trial records.

Quest Life Sciences was issued a notice of concern by the World Health Organization after an inspection last October of a facility in Chennai, India. The agency was reviewing work involving a clinical study of AIDS drugs, but the problems were big enough that the WHO recommended rejecting the study, the notice said.

The article went on to say when the WHO inspectors arrived, Quest employees were still filling out forms for the study. And as inspectors entered the room, the Quest staff attempted to hide some of those documents, according to the notice. The WHO staffers later determined that some of the paperwork was actually backdated.

Read the full WSJ article