SERVICES&CASE

SERVICE

Pharmacovigilance & Safety Handling Services

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.

 

 

 

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