Professional and high-tech services
Strong guarantee for high-quality Clinical Trial data
Pharmacovigilance
We provide integrated drug safety data collection, management, analysis, coding, and reporting services for pharmaceutical companies/CRO companies, based on the PVS system and following the ICH E2B R3 standard. We are committed to providing customers with multi-dimensional and full life cycle drug business support, assisting in the standardized construction of enterprise drug safety systems, and jointly assisting in patient medication safety.
ServiceContent
Safety management plan(SMP)
Database UAT testing
SAEs collection, processing, classification and entry
Data Quality Control
Medical coding
Medical Review
ICSR Reporting
Development Safety Update Report(DSUR)
Risk management Plan(DRMP)
Pharmacovigilance management documentation maintenance