CASE STUDY Reaching Challenging Timeline Goals in Global Post-authorization Safety Study (PASS)Reaching Challenging Timeline Goals in Global Post-authorization Safety Study (PASS) Regions North America (Canada) Latin America Western Europe Central Europe Eastern Europe Middle East Africa Asia Pacific STUDY DESCRIPTION A global real world safety study program was mandated by various regulatory bodies to confirm the risk-benefit profile for a novel oral anticoagulant. The first study generated data on the study drug’s efficacy at reducing strokes in patients with atrial fibrillation. The second study collated data from patients treated for acute deep vein thrombosis with either the study drug or standard of care (SOC). Both studies investigated the bleeding risk associat

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