Safety and Pharmacovigilance
At Confidence Pharmaceutical Research, our Safety and Pharmacovigilance services support the full clinical development lifecycle—from first-in-human studies to regulatory submissions. With decades of global experience, our team ensures patient safety, regulatory compliance, and confident decision-making across every phase of your trial.
How We Do It?
- Strategic Safety Management
- Plan and validate safety processes from Phase 1 onward
- Integrate safety oversight with Medical Monitoring, Regulatory, Biostats, and Medical Writing
- Conduct continuous safety surveillance aligned with regulatory expectations and real-world risks
- Support both single studies and multi-trial programs with scalable oversight
- Regulatory-Aligned Execution
- Deliver global compliance with local knowledge across EU, UK, U.S., and more
- Provide qualified EU Qualified Person for Pharmacovigilance (QPPV) and Responsible Person (RP) services
- Ensure full adherence to regional pharmacovigilance requirements and timelines
- Comprehensive Safety Services
- Setup and maintenance of validated safety databases
- Case processing for adverse and serious adverse events (AEs/SAEs)
- Medical review and clinical safety assessments
- Ongoing literature monitoring for global signal detection and compliance
- Periodic safety reports (PBRER, PSUR, DSUR)
- DSMB coordination and reporting support
What Sets Us Apart?
- Decades of hands-on safety and medical monitoring experience
- Strategic planning from early-phase trials through regulatory submission
- Cross-functional coordination for faster, higher-quality safety reporting
- Scalable systems built for global trials and audit readiness
- Patient-centered safety processes that support both oversight and operational efficiency