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Safety

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Clinical Safety Operations

With Quintiles, you can choose a complete safety package or outsource the individual services you need.

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Case Study

Coordinating Safety Across Functions and Phases

A customer faced significant challenges with clinical and post-marketing safety. Without previous drug safety experience, they needed an ally who could provide a full range of safety and risk management solutions.

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Oversight Group Management Services

Quintiles provides a high level of experience, expertise and customer service to the entire clinical trial process. This is especially true for the oversight group management service, known as CEVA.

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Fact

Quintiles project managers have an average of 7 years of project management experience.

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Learn more about Safety & Risk Management

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