Pharmacovigilance
Patient safety is critical to every study. We plan to offer a comprehensive suite of clinical pharmacovigilance and safety monitoring services in a variety of therapeutic areas.
- Medical Monitoring
- Coding of adverse events and medications (MedDRA and WHO Drug)
- Review and management of suspected serious adverse reactions
- Preparation of MedWatch and CIOMS forms
- Preparation of safety narratives
- Individual Case Safety Report (ICSR) processing for serious adverse events
- Management of adjudication and data safety monitoring committees