Systematic Risk Assessment for Risk-Based Monitoring
Risk Management, RMPs, and REMS
Systematic Risk Assessment for Benefit-Risk EvaluationA Systematic Risk Assessment is a process of comprehensively and methodically identifying the risks in a process. Our approach uses industry standard tools, based upon ICH Q9 Guidance for Industry on Quality Risk Management. Systematic approaches of assessing risk create a defensible body of evidence that can be used to assure stakeholders, particularly regulators, that all risks have been rigorously identified and controlled. Ad hoc approaches to risk assessment cannot achieve this level of defensibility.