This case study outlines a global real-world safety study programme that was mandated by various regulatory bodies to confirm the risk-benefit profile for a novel oral anticoagulant.

The first study of the programme was designed to generate data on the effectiveness of the study drug to reduce the risk of stroke in patients with atrial fibrillation. The second study was designed to collate data from patients treated for an acute deep vein thrombosis with either the study drug or Standard of Care. Both studies investigated the bleeding risk associated with the study drug.

A leading pharmaceutical company selected PRA’s late phase services (LPS) division to conduct two post-authorisation safety studies (PASS) to evaluate the risk-effectiveness profile of a highly innovative blockbuster oral anticoagulant drug throughout global markets.

The LPS team contended with each study challenge through our superior operational design aligned with product approval and uptake, use of innovative analytics to identify trends and risk, and commitment to global transparency