We would be pleased to assist you with your pharmacovigilance obligations under the conduct of clinical and non-interventional studies.

We will be glad to support you in preparing:

  • MedDRA-Coding of adverse events
  • MedDRA-Coding of product or procedural deficiencies
  • AE / SAE management
  • SUSAR-reporting (E2B) to the Ethics Committees / competent authorities
  • DSUR preparation (Development Safety Update Report)
  • PSUR preparation (Periodic Safety Update Report)
  • Collection, processing, review and assessment of individual case reports (ICSR notification (E2B))
  • Forwarding of individual case reports, data reconciliation and final report

For pharmacovigilance services in the full service area, we cooperate with partners that complement our services.