Clinical Trials Unit successfully certified

Neurological examination in the setting of a clinical study: close-up of the Nine-Hole-Peg test of a participant in the Clinical Trials Unit in Bonn. Source: DZNE/Frommann

Following the Clinical Research Platform (CRP), the Clinical Trials Units (CTU) at the Center for Clinical Research in Bonn has now also been successfully certified in accordance with DIN EN ISO 9001:2015 as part of a joint certification process.

The Clinical Research Platform (with the areas of Project Management, Data Management, Trial Design and Statistics, Central Contact Management, Clinical Research Biobank as well as Quality Assurance and Quality Management) supports and coordinates the multi-site studies of the DZNE and provides an organizational framework within DZNE's Clinical Research for the planning, conduct and evaluation of clinical studies and the collection of all data as well as biobanking under standardized conditions.

The Clinical Trials Unit (CTU) provides facilities and technical equipment for the conduct of non-interventional and interventional clinical trials in both outpatient and inpatient settings. An experienced study team of physicians, neuropsychologists, study assistants and technical assistants, who work closely together with the University Hospital Bonn, ensures professional and competent conduct of the studies.

The CRP started to establish and implement a quality management system already in 2013. This was certified for the first time in 2017 and successfully re-certified in 2020. In January 2023, the CRP and CTU were merged into a joint quality management system as part of a successful joint certification according to DIN EN ISO 9001:2015.