Certifications

Our Quality Management Division is responsible for overseeing the maintenance and continual development of the internal Quality Management System (QMS). The primary objective of the internal QMS is to support the various service divisions in regulating and documenting their core processes, ensuring adherence to legal and scientific principles, and meeting quality requirements. Clear and well-documented processes are crucial for ensuring compliance with the legal framework governing clinical trials, while also enhancing efficiency, effectiveness, and transparency.

Established in 2012, the QMS has undergone continuous development, expansion, and structuring, including the introduction of a risk-based approach and the promotion of a comprehensive error and safety culture, along with the implementation of internal audits.

 

We are ISO Certified

Both units CTU Bern and CIU are ISO 9001:2015 certified, demonstrating their commitment to quality management standards.
This certification encompasses our services in Consulting, Regulatory Affairs, Clinical Study Management, Data Management, Statistics and Methodology, Monitoring, and on-site management (Clinical Investigation Unit).

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