The Clincal Trials Unit of the DCR, CTU Bern, underwent inspections by Swissmedic in 2011 and 2013 as part of the initial setup of the CTU Quality Management System (QMS). Since then, we have continuously developed our internal quality structures, resulting in today's ISO 9001:2015 certified quality management system.
In addition to these initial inspections, sponsors have conducted audits to verify overall study compliance and conformity with ICH-GCP, ISO 14155, FDA, and other applicable requirements.
Furthermore, the Clinical Trials Unit and the Clinical Investigation Unit are audited annually as part of their ISO 9001:2015 certification.
For all audits and inspections conducted at any DCR unit, appropriate corrective and preventive actions have been developed and implemented to ensure the continuous improvement of our quality management system and processes.
