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

- Last updated on GMT

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

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