Audits
In terms of quality assurance the sponsor is often interested in audits performed by an external expert to verify that all study-related activities and documents are carried out according to protocol, sponsor SOPs, GCP and legal regulations.
Our company offers the planning, conduction and documentation of audits at one or several study centers, at the sponsor (e.g. process audit, review of study related documents like study protocol, patient information etc.) or at a CRO contracted by the sponsor.
Our service range includes
- Conducting and reporting of audits at study sites, CROs or the sponsor
- Development of preventive action plans based on audit results
- Tailor-made planning of the audit in agreement with the client