On 24th-25th of September 2015 Artem Andrianov, CEO of Cyntegrity, speaks on 20th DGGF International Meeting in Ulm, Germany.
DGGF (German Society for Good Research Practice) is a platform to discuss quality management in pharma world. The CEO of Cyntegrity Artem Andrianov speaks about experience of application of risk-based monitoring (RbM) in clinical trials within a scientific project PUEKS (cooperation with Goethe university, Fraunhofer Institute and PPH plus CRO).
The caption of the presentation is: “The PUEKS project – Process Optimization in Clinical Trial Monitoring”. A summary of the methodology to be implemented in the PUEKS project will be presented.
The PUEKS project, which unites four companies and academic organizations, focuses on the evaluation and optimization of 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.
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