Platform for research quality management

In Switzerland, there is a legal requirement for clinical trials to be conducted in accordance with the international guidelines of Good Clinical Practice. Among other things, a quality management system is required for all phases of the clinical trial.

CTU Balgrist was commissioned by the hospital management to introduce a standardized research QMS platform for the controlled management of research documents at the clinic. 

The intuitive web application “ORCA”, which was developed by the Department of Clinical Research Basel specifically for the needs of academic clinical research as a GCP, Swissmedic and FDA-compliant system, was selected for this purpose.
Consisting of representatives from various research groups at Balgrist University Hospital, a central research QMS committee coordinates the clinic-wide documentation of general research processes, e.g. how clinical studies are to be submitted, conducted or archived. In addition, research groups have the option of supplementing the required documentation with study- or department-specific work instructions.

Are you a sponsor-investigator planning a clinical trial at Balgrist University Hospital?
CTU Balgrist will be happy to introduce you to the existing research QMS or support you in the creation of study-specific QM documents within the ORCA platform.

With our wide range of services, we provide competent support for your research in the implementation of your clinical trial and thus contribute to the success of the project. We look forward to hearing from you!