Audit and quality control
As part of our permanent staff, we have a fully accredited ICH-GCP auditor certified by the Paris Descartes University.
Our auditor has hands-on experience as a Monitor and Project Manager herself. She is familiar with the requirements of the industry and the reality of the Sites.
We are happy to:
- perform audits on your procedures and/or clinical trials;
- do site audits;
- QC your study documentation;
- help you get prepared for inspections by Sponsors, regulatory authorities (e.g. FDA);
- participate to and document your vendor selection process.