SwissPedNet implemented a Quality Management System (QMS) for the clinical pediatric hubs.
The clinical pediatric hubs commit themselves to aligning their activities in accordance with the Quality Policy of SwissPednet.
The QMS of the pediatric hubs is based on the existing QMS of the Clinical Trial Units (CTUs), but supplemented with specific pediatric documents.
A common Quality Management System has the following aim:
- Harmonization of operational activities within the clinical pediatric hubs.
- Continuous improvement of quality and performance of the clinical pediatric hubs.
- Continuous improvement of the quality of clinical pediatric research.
The QMS is a three pillar QMS:
Pillar 1: General GCP adherence >>>
Pillar 2: Local processes - hub specific >>>
Pillar 3: Pediatric specific standards >>>