A large biotech client awarded PRA a full-service contract to perform a Phase IIb study of hepatitis C drugs with a target to enrol 240 subjects in 130 global sites.

Changes in resources for both the client and PRA teams led to significant challenges with the start-up and enrollment activities in Europe and North America.

Because the study’s enrollment criteria and endpoint involved invasive procedures, project team members questioned whether sites would be interested and if the subjects could be enroled in a reasonable time or at all.

The client expected PRA to overcome these obstacles and follow the contracted timelines.