CTU Bern (Clinical Trials Unit)

Quality Management

The CTU Bern has its own quality department, which is responsible for the internal quality management (QM).

The aim of the internal QM is to assist the five different divisions of the CTU to regulate and document their core processes by considering legal and scientific principles and quality requirements. Well-defined and documented processes ensure that the legal foundations of conducting clinical trials are met, while ensuring efficient, effective and transparent processes are followed.

The Quality Management System (QMS) of the CTU Bern was set up in 2012 and has since been continuously developed, extended and structured, taking into account internal and external influencing factors. As an example, the risk-based approach was introduced in 2016 alongside with a comprehensive error and safety culture, which is actively promoted within the CTU. Since 2017 internal quality measurements and audits have been carried out and are a strong tool to measure compliance and overall adherence to regulations.

ISO 9001:2015 certificate (click to enlarge)

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.