PPH plus – The Innovation Winner with the PUEKS Project
PPH plus has embarked on the PUEKS project on 1 December 2014, as a winner and consortium partner from the research and development project applications in the framework of the Hessen ModellProjekte.
The PUEKS project will devote a year and a half to the evaluation and optimization of Risk-based Monitoring. For this purpose, PUEKS will use data already 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 in clinical trials.
This project depicts the importance of the collaborative efforts between industry, research institutes and academia. Thus, the project initiative of the consortium manager Cyntegrity , our RbM partner offering innovative technologies to biopharma, has been joined, apart from PPH plus, by the Institute of Biostatistics and Mathematical Modeling at the Goethe University, and the Fraunhofer Institute IME TMP.
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).