Key Risk Indicators (KRIs) are derived from both Operational and Clinical Data and allow the monitoring of study conduct every two weeks. The enhancement of the engine with the KRI+ approach provides users with the powers of statistical analysis alongside their own triggers for action across key operational variables. This means that more frequent operational analyses can be conducted, and, when coupled with an exhaustive interrogation of all clinical data, the software ensures that sponsors can de-risk studies and improve data quality and integrity using an automated and objective approach.
The resulting KRI dashboard uses a user-friendly, familiar traffic light system to easily identify sites at risk and the reasons why based on objective statistical results, unlike any other solution. It is very straightforward for Clinical Study teams to focus on areas of risk and predetermine actions arising based on a limited number of risk indicators.
Frequency = continuously if required but likely every 2 – 3 weeks