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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?

  • 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
  • Deliver global compliance with local knowledge across EU, UK, U.S., and more
  • Provide qualified EU QPPV and Responsible Person (RP) services
  • Ensure full adherence to regional pharmacovigilance requirements and timelines
  • 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?

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