CTU Bern

Audits and Inspections

CTU Bern was inspected by Swissmedic in 2011 and 2013 as part of the initial set-up of the CTU Quality Management System (QMS). Since then, the internal quality structures have continuously been developed into today’s International Organization for Standardization (ISO) certified quality management system.

In addition to the initial inspections, audits were conducted by sponsors in order to verify overall study compliance and conformity with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guideline (ICH-GCP), ISO 14155, US Food and Drug Administration (FDA), and other applicable requirements. Besides, CTU Bern is audited annually as part of its ISO 9001:2015 certification.

For all audits and inspections conducted at CTU Bern, appropriate corrective and preventive measures and actions were developed and implemented to ensure continuous improvement of its quality management system and processes.

 

List of inspections and audits received to date:

 

Institution Year Date Reason Findings
Swissmedic 2011

23.05.2011
24.05.2011

Initial GCP System inspection 29 (no classification made)
Swissmedic 2013

07.03.2013

GCP system re-inspection and focus on Clinical Investigation 2 major, 1 minor
Cardialysis/European Clinical Research Institute (ECRI) 2018

21.03.2018
22.03.2018

Study protocol compliance, GCP, ISO 14155 and FDA requirements 1 major, 3 minor

5 recommendations

Halloran/Boston Scientific 2019

11.06.2019
12.06.2019

Study management, data quality and integrity for the SCOPE I study 1 major, 2 minor

1 recommendation

QS Zürich 2019

07.02.2019

ISO 9001:2015 Stage 1 – Zertifizierungsaudit ---
QS Zürich 2019

09.04.2019
10.04.2019

ISO 9001:2015 Stage 2 – Zertifizierungsaudit 1 major, 1 minor
QS Zürich 2020

18.06.2020

ISO 9001:2015 Überwachungsaudit 1 minor
QS Zürich 2021

12.05.2021

ISO 9001:2015 Überwachungsaudit TBD/upcoming audit