PRA Health Sciences (PRA) experts have significant experience providing end-to-end risk management services. Our integrated global teams identify innovative solutions to satisfy key regulatory requirements and provide effective strategies to ensure the benefit-risk profile of the product remains favorable for patients.
Pharmacovigilance Nugget #3 The Challenges of Effective PSMF Maintenance - December 2018
The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU). A PSMF shall describe the pharmacovigilance (PV)…
Sponsor and CRO Pharmacovigilance Alliances
Outsourcing pharmacovigilance activities is a standard business practice in a continuously expanding market segment. In the past, outsourced safety…
Pharmacovigilance & Patient Safety
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them.