PPS admits falsifying record for a 2007 trial of Boehringer’s ‘female viagra’

US CRO PPS Clinical Research has admitted that an employee falsified patient record during a trial of Boehringer Ingelheim’s failed ‘female Viagra,’ Flibanserin.

According to a report in the St Louis Post-Dispatch​ – a PPS employee who worked on the 2007 trial altered records to suggest that a patient who dropped out of the programme in December had continued to participate and had even turned up for an examination the following June.

Jim Crowe III, a lawyer representing PPS, told the Missouri Court the employee's “serious health issues that led her to not perform her job properly and (she) did some things that rendered (her actions) difficult to detect."

PPS pled guilty and also admitted it had "corruptly influenced, obstructed, and impeded" an inspection by the US Food and Drug Administration (FDA) in May 2010 by providing false patient records and agreed to a $68,000 fine.

Related topics Clinical Development Phase III-IV

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Related suppliers

Follow us

Products

View more

Webinars