Quality and Risk Management

In line with the Quality Policy of the Insel Gruppe our Quality and Risk Management is based on a quality culture that focuses on the welfare of our study participants and represents our commitment to achieving highest quality standards, successful clinical research and continuous improvement. For this, we have implemented a framework to meet the increasing quality requirements for clinical research, to manage quality in all phases of the research process and to ensure compliance with Good Clinical Practice (GCP), with the approved protocols/amendments and with the applicable legal provisions.

A systematic and risk based approach combined with pro-active issue management allows us to make sure that our resources are best targeted to address the most important issues and priorities, especially those associated with the wellbeing of our study participants and the quality and reliability of study data and results.

To support regulating the processes from research planning through conduct to completion, the Directorate of Teaching and Research provides research guidelines, document templates and Standard Operating procedures (SOPs) which are available to all Insel Gruppe AG employees on the Intranet: Studienkompass Insel Gruppe. The Studienkompass provides comprehensive practical support in the implementation of research projects in accordance with the Human Research Act (HRA), the Ordinance on Human Research (HRO), the Ordinances on Clinical Trials in Human Research (ClinO/ClinO-MD) and the ICH/ISO Good Clinical Practice Guidelines.