Azelix’s highly specialized product safety experts are composed of physicians, registered nurses, and clinical pharmacists. They are a critical part of our project team helping to ensure the safety of subjects and ensuring that reporting requirements are met. Our product safety team will provide safety profiles through management and analysis of the safety data, and ensure rapid exchange of safety information among all parties.

Azelix’s pharmacovigilance services include:

  • Development of Safety Management Plans
  • Processing/Reporting of SAEs and Other Events of Interest
  • SAE Listing and Summary Tabulation Generation
  • Event Narratives
  • Regulatory Report Submission for SUSARs
  • Database Reconciliation
  • Coding Review (per MedDRA and WHO Drug)
  • Signal Detection and Management