Systematic Risk Assessment
for Risk-Based Monitoring
Systematic Risk Assessment for RBM
What is Systematic Risk Assessment for RBM?The first step in any risk-based monitoring planning is the assessment of risk. A Systematic Risk Assessment is a process of comprehensively and methodically identifying the risks in a process.
What makes the ParagonRx approach to RBM unique?
Our approach uses industry standard tools, based upon FDA/ICH Q9 Guidance for Industry on Quality Risk Management, including Root Cause Analysis, Failure Mode and Effects Analysis, and Hazard Analysis and Critical Control Points. 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.
The findings of the Systematic Risk Assessment guide the development of clinical functional plans, the configuration of central monitoring technology platforms, and the design of monitoring workflow.