Conducting an audit during your clinical trials is an important factor that improves the quality, accuracy and reliability of clinical data to be obtained.
We audit objectively and independently the centers where clinical trials are carried out within the framework of
- Good Clinical Practices (GCP),
- Clinical investigation of medical devices for human subjects EN ISO 14155:2012
- Local requirements
and we examine whether the study is carried out in accordance with the requirements of national standards, approved study protocol and requirements of SOPs, and then, reports and, upon request, a certificate indicating that the Clinical Research is audited are prepared.