Benefit-Risk Management Services

Risk & Benefit-Risk Analysis

PrimeVigilance has significant industry experience in setting up and performing different types of Risk Analyses.

We apply methods such as the Zurich Hazard Analysis (ZHA) for the prioritisation of important risks, the Failure-Modes and Effects Analysis (FMEA) for the analysis of safety relevant processes (e.g., patient selection, prescription, or home use of medicines), or Fault-Tree Analysis for the investigation of root causes of complex risks. PrimeVigilance supports clients in developing Benefit-Risk Frameworks for the qualitative assessment of BR profiles of drugs, and offer our services in the selection and execution of appropriate quantitative BR analysis methods, with hands-on experience in performing Multi-Criteria Decision Analyses (MCDAs). PrimeVigilance also partners with experts in the elucidation of stakeholder preferences through conjoint analyses or discrete choice experiments.