Serious Adverse Event Reporting (SAER) is a mandatory requirement for federal health agencies and also involves patient follow-ups. It often involves a robust compliance program to monitor a product after it goes to market. Along with our gold-standard Adverse Event Reporting / Adverse Reaction Reporting services, dicentra also offers pharmacovigilance services that are tailored specifically to meet the needs of any clinical trial, regardless of what phase it is in.
Our range of services includes:
- Development and implementation of pharmacovigilance systems for investigational and registered products
- Triage services to handle reports of events and product complaints
- Customized safety plan and safety data exchange agreement
- Individual Case Safety Report (ICSR) management
- Literature search and identification of ICSR and safety issues
- Regular reporting on all events, including post-market safety summaries, benefit/risk assessments, clinical overviews, and more
- Medical review of safety reports and documents, assessing the need to take regulatory action
- Reporting events and reactions to Health Authorities (HA) and Independent Ethics Committees (IEC) / Institutional Review Boards (IRB)
- Statistical Analysis of events and reports for signal detection and ongoing safety evaluation
- Pharmacovigilance consulting
Contact dicentra to learn how our pharmacovigilance services can support your clinical research goals