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
