Pharmacovigilance and Medical advisory for clinical trials
QuailCRO project managers have the background, training and experience to process AE and SAEs, to ensure complete and accurate safety information to the sponsor and EC.
Provides customized QuailCRO safety SOPs and forms or implementing sponsor safety procedures
Electronic submission of ICSR according to Vol 9A (Human Pharmacovigilance)
Procedures for reporting in compliance with ICH E6 and E2A Guidances, Directive 2001/20/EC, EC Guidance April 2004, CFR Title 21/312.32 and Romanian MoH orders
Submits PSURs, SUSARs, Annual Safety Reports and IDBs updates
Provides input on protocol and Annual Safety Reports
Ensures medical advisory support 24 hours per day for sponsors and investigators
Provides Consultancy and Safety monitoring to reconcile SAEs between the investigators and Pharmacovigilance database
Receives, validates and PV forwards of SAE from Investigators to sponsor
Study dedicated Fax lines for investigators SAE reports and SAE Follow-ups .