Fiore Healthcare Advisors (FHA) provides Pharmacovigilance and Clinical Research consulting to help pharmaceutical, biotechnology, and other life science companies protect their patients and their assets.
Our team of former Heads of Safety, provide expert Pharmacovigilance (PV) consulting to client companies of all sizes. We work with product experts to design appropriate PV strategy, review and analyze PV data, required safety documents, and present safety data as needed.
Our clinical trials experience and capabilities include design and execution of clinical development plans/programs, designing and implementing measures to improve oversight of clinical programs, improving vendor performance, and all aspects of data review. We have particular expertise in training sites and staff in PV information handling as well as safety and medical monitoring.
Our compliance experts perform high quality Clinical and PV auditing to ensure your clinical research programs and PV operations and system meet the most rigorous quality and regulatory standards. We audit to standards set by the US FDA and the European Medicines Agency’s Good Pharmacovigilance Practices.
Partnerships enable us to achieve greater results together. We are eager to apply our expertise and passion for safety and clinical research and help address your business challenges as they were our own.