Participant safety and the quality and reliability of studies are the foundation of our work.
What the system consists of
- standard operating procedures (SOPs) and other quality management documentation;
- internal and external audits of the clinic;
- regular external audits of subcontractors;
- systematic staff training.
Inspections and audits
We are ready for a sponsor’s qualification visit and audit. What is usually checked — see “How to evaluate a clinical study site”.
How this relates to a study
Quality is built in from the start: at the feasibility assessment stage we check the protocol against the capabilities of the site, and the study documents are reviewed by the ethics committee.
See also
Clinic licences and permits
The clinic conducts clinical studies under a licence for medical activities and in line with the principles of Good Clinical Practice (GCP) and its own standard operating procedures.
Learn moreEthics review of study documents
The clinic’s local ethics committee (LEC) reviews the study documents, including the information that volunteers and patients read and sign. It checks that everything has been done to protect their safety and rights.
Learn more