Safety and Pharmacovigilance

Orphanos offers global safety and pharmacovigilance services to assist in all phases of clinical research. Our team provides experience, consistency and dedicated medical and safety staff.
Our services include:

  • Processing of SAEs including medical review
  • Preparation, writing, and distribution of SAE narratives and safety reports (MedWatch, CIOMS) including submission to regulatory authorities
  • AE and SAE reconciliation of safety and clinical databases
  • Medical and safety coverage available 24 hours, 7 days a week
  • Safety Quality Assurance – ongoing review of safety data including monitoring and identifying safety trends
  • Safety training and education
  • Real-time SAE tracking within CTMS