CTU Bern’s quality department, is responsible for the internal quality management of the institute. Well-defined and documented processes ensure that the legal foundations of conducting clinical research projects are met, while ensuring efficient, effective and transparent processes are followed and continuously developed.
In addition to managing the internal structures, the quality management division also offers its expertise to external customers and partners by providing consulting or support services to implement local quality assurance measures, develop procedures or to establish comprehensive quality management structures. In addition, the quality management division can provide active support in the preparation for inspections, the writing of inspection reports, corrective and preventive action development and offers its auditing services to conduct an independent audit on your study or internal process structures.
CTU Bern is ISO 9001:2015 certified
In the first quarter of 2019, the CTU Bern had its QMS externally evaluated, assessed and certified with regards to the services offered. As such, the CTU Bern is successfully ISO certified since April 2019:
The certification to the ISO 9001:2015 Standard on Quality Management System includes the CTU services Project Management, Consulting, Data Management, Statistics, Monitoring and Regulatory Affairs.
The QM team of CTU Bern will be pleased to answer any questions you may have.