Pharmacovigilance

LOGO APICES offers a wide range of services from a single support to your pharmacovigilance department to a complete outsource of the pharmacovigilance sponsor responsibilities established by the last international and national regulations in place. We have internal audited SOPs, but we can also work with the client SOPs, when required. This is a list of the more demanded services we can provide (if you need any other pharmacovigilance service, do not hesitate to contact us):

  • Pharmacovigilance training.
  • Pharmacovigilance Database.
  • SAE reception.
  • Case Assessment (e.g., causality, expectedness).
  • Risk Assessment.
  • Development Safety Update Report writing.
  • CIOMs writing.
  • Notification to Ethics Committees and Health Authorities.