Complex pharmacovigilance legislation in an evolving regulatory landscape has left drug makers searching for current, efficient, and more meaningful solutions for their drug safety challenges, especially in the post-marketing arena. Companies are seeking expert advice and customized approaches to effectively collect, manage, and analyze real-world evidence for a competitive advantage. PRA’s Safety and Risk Management (SRM) and Late Phase Services (LPS) experts provide our clients with unique strategies from years of first-hand experience. PRA’s global SRM and LPS divisions have identified innovative solutions that satisfy key regulatory requirements to meet our clients’ risk management planning and execution needs.

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Risk Management Planning & Mandated Post-Authorization Studies