Our Risk Based Monitoring solution help the sponsor to monitor the progress of trials through Data Mining and Clinical Data Visualisation. Sponsors are facing major challenges in the complex task of monitoring the progress of geographically distributed trials. Genpro RBM solutions are driven by a dynamically configurable rule engine. It helps sponsors and CROs to adopt an agile risk-based monitoring approach throughout a trial. Our RBM framework provides the user with the capabilities to define key performance indicators related to the trial. It also helps the sponsors to assimilate data from the various data sources which will be warehoused and analysed in order to provide actionable insights on the ongoing trials. Some of the features of our RBM module includes the following..
Genpro will work with the sponsor to discover the areas that are critical to the success of the clinical trial and the safety of its participants. These identified risks will be documented and a mitigation plan will be established.
Risk indicators will be further developed and monitored to track the trial progress at clinical sites, and to evaluate whether a structured intervention is required.
Genpro statisticians will predefine the risk thresholds so that any indicators that cross these can be carefully evaluated and appropriate intervention is initiated.
A risk dashboard will be developed and provided to the sponsor which assures a continuous monitoring of risk indicators. Sponsors will also be able to initiate corrective actions from this dashboard.