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Clinical Study Unit

Tasks
The clinical trials unit conducts a wide variety of own investigator-initiated trials. Due to our expertise in clinical pharmacology, the unit is well-equipped to conduct all phase I to phase IV trials locally. In addition, our team supports all investigator-initiated clinical trials at Robert-Bosch-Krankenhaus and Klinik Schillerhöhe (Pneumology/Thoracic Surgery) with regard to protocol writing, approval/ regulatory affairs and advises in questions concerning the conduct/feasibility of the projects. Moreover, we regularly support phase I-IV studies of external sponsors at the different clinical departments of Robert-Bosch-Krankenhaus GmbH. A special research focus at our institution is on pharmacogenetics and personalized medicine. Here, our unit plays a vital role in translating and implementing our basic research results into clinical routine by a bench-to-bedside approach.

 

  • We provide specialized, standardized processes necessary for conducting clinical trials according to the national/international standards in terms of data integrity as well as ethical, legal requirements. The clinical trials unit is responsible for all study-related standard operating procedures (SOPs)
  • Safety of patients or healthy volunteers has the highest priority. All study personal receives training for emergency cases at regular intervals. The premises of the CTU are located within Robert-Bosch-Krankenhaus and therefore, all facilities of a tertiary care hospital (including intensive care and advanced diagnostics) are immediately available in case of emergency
  • The trials unit accommodates three beds. Separate shower facilities as well as television and internet access are provided for all study participants.