The term Good Clinical Practice (GCP) includes the internationally recognized standards for conducting clinical trials on humans.
During a GCP audit, a systematic and independent review of the activities and documents related to the clinical trial is carried out to determine:
- whether the checked, study-related activities were carried out in accordance with the test plan, the Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable legal provisions
- whether the data have been documented, evaluated and correctly reported in accordance with these requirements.
At the same time, this enables the mutual recognition of study results from the EU, the USA and Japan.
In the area of GCP we offer the following audit types:
- Clinical Study Protocol
- Investigator Site (including Pre-Inspection Audits and FDA Mock Audits)
- Clinical Study Report
- Trial Master File
- Internal Systems
- External Systems (including CRO, Software Provider and Due Diligence)
We would be happy to support and advise you individually as part of the implementation of your audit/audit program.