PRA was awarded a global Phase II safety and tolerability study of a drug with a novel action for the treatment of coronary artery disease.

The study involved more than 130 sites and 700 patients. It encountered many challenges due to last-minute design and operational changes and tight timelines. Regardless, PRA completed the study successfully, thanks to its project team’s determination and innovation.

This study required PRA to achieve milestones under extremely challenging timelines and operational logistics. For example, the team had to execute a late requirement to fully lock 90% of the subjects five months earlier than originally planned. This initiative required fast implementation of a patient profile review process, which also had not been previously required, and reconciliation across six vendors.