Safety event collection and processing
• CFDA recent issuing of AE/SAE handling guidelines
• US FDA & EMA AE/SAE handling guidelines
Coding: AE/SAE MedDRA, Medications: WHODRUG
DSMB/DMC and risk management planning
Fountain offers services in addition to AE/SAE collection and reporting including, but not limited to, coding, safety database build-up, reportability assessment process, establishing and operating a qualified Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC), signal detection and risk management planning.