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Pharmacovigilance and Safety
Safety and Pharmacovigilance


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GENERAL CAPABILITIES




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Medpace can orchestrate full-service global safety programs for postmarketing projects, taking into account necessary components covering consultation on complex safety profiles, operational excellence, data collection and analysis design, case processing, medical review and reporting, with an advanced understanding of regulatory requirements over the lifespan of the compound. Postmarketing Safety team members have healthcare related degrees to better manage data intake and initial assessment as well as case compliance and quality when performing the services offered.

Services include the following:

  • Adverse Event (AE) and Product Complaint (PC) management
  • Individual case reporting
  • Call Center Function
  • Safety database services
  • Global literature monitoring and routine media monitoring search strategy and review
    • Medpace utilizes outside vendors to help manage the routine monitoring process of the scientific literature and media
  • Safety signal management
  • Aggregate report management
  • Region-specific pharmacovigilance management
    • Maintenance of a certified pharmacovigilance system (i.e. PSMF) for pharmaceutical companies in the EU
    • European Union-qualified person for pharmacovigilance (QPPV)
    • In-country pharmacovigilance services, including local literature surveillance and national contact persons
    • EudraVigilance profile management
    Want to learn more about ClinTrak? Visit ClinTrak®