In compliance with national regulations and ICH guidelines, the PV team provides clients with pharmacovigilance solutions covering the entire drug lifecycle. We have established a complete product safety information database to efficiently control risks in real-time, implement risk management from a pharmacovigilance perspective, and provide reliable and professional support to ensure the medication safety of research participants.
Review of drug safety data
Individual case report handling/review/submission
Writing/submission of safety documents such as DSUR
PV database configuration/testing/running and maintenance
Safety signal detection/evaluation/management
Post-marketing safety surveillance