A project with the aim to standardize an RBM approach in clinical trials. It unites four companies and academic organizations, focuses on the evaluation and optimization of Risk-based Monitoring (RbM). For this purpose, PUEKS will use data available from past clinical studies to select substantiated key risk indicators (KRIs). Subsequently, the obtained data-driven KRIs will be tested in an ongoing trial. A comparative evaluation with historical data from past studies will be additionally performed to evaluate the power of the selected KRIs in terms of cost savings, enhanced quality, and risk mitigation. The project is aimed at delivering a robust RbM tool as well as an optimized procedure for the successful implementation of RbM.
This project (HA project no. 448/14-38) is funded in the framework of Hessen ModellProjekte, financed with funds of LOEWE – Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz, Förderlinie 3: KMU-Verbundvorhaben (State Offensive for the Development of Scientific and Economic Excellence).