Safety and Pharmacovigilance services at Confidence offer comprehensive solutions to navigate the complexities of regulatory compliance in safety reporting, safety assessment and benefit-risk management for new drugs, biological products, and medical devices.
With decades of collective experience, our team specializes in medical and safety management of international clinical trials. Our aim is to safeguard patients during development process and support the success of clinical trials.
At Confidence Research, we recognize the critical importance of appropriate planning and setup of safety management processes from phase 1 trial to submission for marketing authorization. This goes far beyond the safety database and case processing. Our Safety and Pharmacovigilance Services are designed to navigate our clients through every aspect of safety data collection, analysis, and reporting, including multidisciplinary cooperations between different vendors and teams (data management, biostatisticians, central labs, medical writers, regulatory operations).
Service Overview:
- EU Qualified Person for Pharmacovigilance (EU QPPV)/Responsible Person (RP)
- Safety database setup and maintenance
- Case processing
- Safety Surveillance
- Literature Monitoring
- Periodic safety reports (PSLL, DSUR, etc.)
- Medical Safety
- Data Safety Monitoring Boards (DSMB) management