Quality Assurance / Audit

Services:

We offer quality assurance / audits at all stages of a project, from study protocol to final report. Of course, you may select any individual modules of each service.

Quality assurance / Audits:

• Study protocol
• Patient- (volunteer-) information / informed consent form
• Case record form
• In-house Audit
• Study Medication
• Data base audit
• Final report
• On-site audits (national and international incl. Check of FDA-conformity)
• system-audit (Sponsor, CRO, Laboratory)

All checks will be performed according to ICH-GCP, the currently valid laws and guidelines and the respective SOPs (Sponsor and/or AMS as agreed).

If you wish, we are able to perform audits to ensure acceptance of your project by the FDA.