In this white paper, best practices are described as well as required Sponsor/Local Representative agreement areas. It is important that major subject areas are agreed in order to ensure that the conduct of the clinical trial does not cause issues when the new drug application is assessed by the competent authorities. Although Local Representation applies to multiple areas of Pharmaceutical Development (Regulatory, Legal, etc.), this Whitepaper is limited to the area of Pharmacovigilance.
Pharmacovigilance & Patient Safety
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them.
PRA Leads Novel Multiple Myeloma Drug Development
PRA Health Sciences supported 2 multiple myeloma clinical trials, a Phase III and a “rollover,” for a large biotech client. This management contract…
Risk Management Services
PRA Health Sciences (PRA) experts have significant experience providing end-to-end risk management services. Our integrated global teams identify…