It’s a one-of-a-kind word for our one-of-a-kind approach.
Fiore Healthcare Advisors delivers pharmacovigilance support and service at the highest levels of quality and satisfaction ensuring patient safety and compliance by improving the overall strategy, efficiency and quality of your PV organization.
In a word, PHARMACOEXCELLENCE.
Our accomplished team of highly-trained medical professionals provide scientific discipline and expertise to analyze and evaluate potential safety issues in a manner that focuses on driving to conclusions and appropriate actions. Our management and oversight programs ensure consistent, high quality and compliant deliverables resulting in outstanding process and cost efficiencies
- Our pharmacovigilance physicians and scientists work with existing client teams or independently develop expertise to create a robust PV plan for any product
- Performing medical review and analysis of individual case safety data or aggregated data, applying expert PV judgment to form conclusions and identify next steps
- Reviewing data from multiple sources to determine safety profile
- Developing core documents – Investigator Brochure, Core Data Sheet, Risk Management Plan
- Identifying and implementing a tailored signaling strategy
- Performing all aspects of signal management
- Designing and executing post-marketing clinical registries
- Designing and executing prospective surveillance similar to FDA PROMPT
- Responding to Health Authority inquiries
- Handling urgent safety issues
- Performing hazard analysis for potential recalls
FHA’s independent Chief Safety Officer (iCSO) services are designed to supplement internal Medical Directors and Chief Medical Officers in companies where the volume of safety activity is not sufficient to support an internal safety team, or if there are staffing gaps due to staff attrition.
A structured team with appropriate expertise and experience is organized so as to optimize the matching of skills and roles with the project’s goals and objectives.
- Safety system review and optimization/design
- Safety data review and analysis
- Executive level safety activities
- Designing and implementing Risk Based Monitoring to ensure patient safety and data integrity
- Implementing data visualization techniques to facilitate review
- Reviewing comprehensive clinical trial safety data
- Authoring the safety section of clinical trial protocol
- Authoring the Investigator Brochure
- Authoring the Integrated Safety Summary
- Providing investigator and site safety training
- Provide Vendor oversight and operational quality assurance
- Perform data review and signal management
- Author policies, SOPs and all safety documents such as:
- DSUR, PADER, PBRER
- Reference Safety Information/Labeling/IB
- Safety/Signal Management Plans
- Safety Governance strategy and charter development