Pharmacovigilance Services

Fiore Healthcare Advisors are pharmacovigilance experts. We provide scientific discipline and expertise to analyze potential safety issues in a manner that is geared toward driving to conclusions and appropriate actions.

  • Our pharmacovigilance physicians and scientists will work with existing client teams or independently develop expertise to create a robust PV plan for any product
  • We perform analysis of individual case safety data or aggregated data, applying expert PV judgment to form conclusions and determine next steps
  • Review data from multiple sources to determine safety profile
  • Develop core documents – Investigator Brochure, Core Data Sheet, Risk Management Plan
  • Determine and implement signaling strategy
  • Develop and implement proactive postmarketing surveillance strategy
  • Perform all aspects of signal management
  • Design and execution of postmarketing clinical registries
  • Design and execution of prospective surveillance similar to FDA PROMPT
  • Respond to Health Authority inquiries
  • Handle urgent safety issues
  • Perform hazard analysis for potential recalls
  • Perform review of the pharmacovigilance system or selected elements to identify risk areas or gaps
  • Perform simulation of effects of stress on different points in the system to determine areas for requiring additional attention
  • Evaluate business continuity and disaster recovery plans to ensure robustness and accessibility
  • Design key elements of the system using our proprietary 6-TTM methodology.

We offer independent Chief Safety Officer (iCSO) services designed to supplement internal Medical Directors and Chief Medical Officers in companies where the volume of safety activity is not enough to support an internal safety team or if there are staffing gaps due to attrition.  We structure a team with different skill levels in order to optimize matching of skills and roles.

  • Safety system review and optimization/design
  • Safety data review and analysis
  • Executive level safety activities
  • Design and implement Risk Based Monitoring to ensure patient safety and data integrity
  • Implement data visualization techniques to facilitate review
  • Review comprehensive clinical trial safety data
  • Author safety section of clinical trial protocol
  • Author Investigator Brochure
  • Author Integrated Safety Summary
  • Provide Investigator and site safety training