Adequately assessing product safety is essential to the success of all clinical research projects and diligent pharmacovigilance is essential for keeping products on the market.

ICON’s Drug Safety Department supports your product’s development by implementing efficient processes, compiling a concise safety profile of your product, and developing a comprehensive risk management plan to get you safely through the approval process.

Once your product is on the market, ICON supports your product with proactive monitoring of the safety profile through ongoing surveillance, signal detection and analysis, and adherence to a pre-planned risk management strategy.

Our highly-trained staff have a proven track record of meeting stringent timelines worldwide, while ensuring complete, high quality data is maintained.

A full-spectrum of services includes:

• Clinical trials safety management
• Total Product Safety Center (TPSC) for seamless provision of
  
  • Postmarketing Surveillance
  • Drug Information Services
  • Product Complaint Management
• Safety Database hosting with electronic regulatory reporting
• Qualified Person for Pharmacovigilance (QPPV) in Europe
• Global interaction with and reporting to Competent Authorities
• Aggregate periodic reporting
• Registry/Postmarketing authorisation study design and implementation
• Safety consulting, including set up of your own Safety Department
• Risk-Management, Crisis Management & Pharmacovigilance planning and auditing