Safety Management & Pharmacovigilance

Monitoring the safety for each study participant collaboratively among all stakeholders throughout the clinical development process is imperative for clinical and regulatory success. Our experienced safety team is strategically positioned to identify trends and signals ensuring appropriate safety of each study. C3 Research offers comprehensive safety management and pharmacovigilance services including:

  • Complete serious adverse event (SAE) and serious adverse device effect (SADE) reporting
  • Develop and maintain the safety management plan (SMP)
  • Create and maintain the study safety database
  • Receive and process safety reports
  • Develop and finalize safety narratives
  • Distribute safety reports
  • Develop and/or review risk management plans
  • Generation of ad-hoc reports and listings from safety database
  • Generate reports for regulatory authority submissions
  • International and United States Regulatory reporting support
  • Reconcile clinical and safety databases