Minimization of risk to patients has always been a top line priority in the context of new medicinal product development. Regulatory authorities, now, more than ever emphasize the importance of appropriate safety management infrastructure. The development of risk minimization strategies suitable for the whole lifecycle of the medicinal product is imperative.
PRA's Safety & Risk Management group has an impeccable record of providing a comprehensive range of pharmacovigilance services throughout the product lifecycle. PRA provides global coverage with four centralized Drug Safety Centers in Europe and the Americas to ensure patient safety and ultimately save resources. Within each Drug Safety Center, our experienced management team leads a group of qualified Drug Safety Associates to provide a full spectrum of services. Achievements during 2010 include:
- Over 100,000 safety letters to EC/IRBs and sites (8,400 per month)
- More than 2,160 individual case safety reports per month
- 630+ Cumulative Safety Reports to Regulatory Authorities per month
PRA's Safety & Risk Management works directly with other PRA groups such as Therapeutic Expertise, Analysis & Reporting and Late Phase Services. By working in cross-functional fashion, PRA can better assist clients in the effective management of their drug safety information.