Pharmacovigilance and medical-device vigilance services for clinical studies

Summary

GHU Paris Psychiatry and Neurosciences is procuring a single contract for pharmacovigilance and medical-device vigilance services for its clinical studies. The scope covers studies involving medicines, medical devices and other health products, including adverse-event handling and reporting, safety reports and documentation, regulatory advice, training, and support for safety reviews. The documents indicate 15 active medicine trials, 10 medical-device clinical investigations and 10 RIPH 1 studies; the forecast also refers to approximately 70 serious adverse events and 5 SUSAR cases per year in 2025.