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