The aim of the project (code-name “PUEKS”, full name “Process Innovation in Clinical Trial Monitoring”) is the development and validation of a Risk-based Monitoring process using robust data-driven risk indicators.

The predictive and preventive power of the risk indicators will be investigated via a retrospective analysis of a finished trial and, subsequently, through their implementation in an ongoing study. Thus, the validity of the risk indicators will be assessed by using actual study data. The benefits of RbM in terms of monitoring cost savings, risk mitigation, and quality improvements will be evaluated against analogous or “twin” studies conducted by the Fraunhofer IME TMP in the past.

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).