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 |
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 |
Study protocol compliance, GCP, ISO 14155 and FDA requirements | 1 major, 3 minor
5 recommendations |
| Halloran/Boston Scientific | 2019 |
11.06.2019 |
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 |
ISO 9001:2015 Stage 2 – Zertifizierungsaudit | 1 major, 1 minor |
| QS Zürich | 2020 |
18.06.2020 |
ISO 9001:2015 – Überwachungsaudit 1 | 1 minor |
| QS Zürich | 2021 |
12.05.2021 |
ISO 9001:2015 – Überwachungsaudit 2 | 1 minor |
| QS Zürich | 2022 |
17.05.2022 |
ISO 9001:2015 – Rezertifizierungsaudit | no observations |
| SCTO (Swiss Clinical Trial Organisation) | 2022 |
16.10.2022 |
System Audit with Focus on QM, IT Infrastructure, Datamanagement | 1 Action strongly suggested
8 Actions suggested |