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Safety & Risk Management
Comprehensive Safety Surveillance: Pharmacovigilance & Risk Management
How you monitor and respond to safety signals throughout a bio pharmaceutical product or medical device’s lifecycle has a profound impact on your product’s success. Quintiles takes a lifecycle approach to help you obtain the most precise picture of your product’s safety profile and help you meet regulatory requirements for pharmacovigilance.
We harness the lessons learned from thousands of bio pharmaceutical clinical trials and the specialized skills of our safety surveillance and risk management professionals. We give you peace of mind – and foresight – by helping you:
- Monitor safety and manage case reports
- Mitigate risk earlier in development
- Monitor, manage and maximize your product's risk-benefit profile
- Improve the market value of your product with proactive planning and robust risk management
Quintiles offers a full range of integrated pharmacovigilance and bio pharmacuetical risk management services, customized to your needs:
- Risk management planning
- Case processing
- Oversight group management
- Post-marketing safety surveillance
- Qualified/responsible person services
- Safety publishing – aggregate reporting and SOPs
- Quality assurance
- Medical information
- Biomedical literature surveillance
- Safety training and education