Systematic Risk Assessment for Risk-Based Monitoring
Risk Management, RMPs, and REMS
Systematic Risk Assessment
for Risk-Based Monitoring
Clinical Trial Process Mapping
What is Clinical Trial Process Mapping?Clinical Trial Process Mapping is a graphical, linear depiction or “roadmap” of the clinical trial process. This process map is developed prior to performing a systematic risk assessment in order to ensure a comprehensive assessment. The map enables ParagonRx to identify key points of risk in the process in a systematic fashion that allows prioritization and scoring to determine the critical data and processes that must be actively monitored to control risks.
What makes ParagonRx approach unique?Our Clinical Trial Process Mapping is unique in that systems engineers and clinical study experts jointly design and develop this “roadmap” to ensure future success in mitigating potential clinical trial risks .
Process Steps of a Typical Clinical Study