GCP audit: an independent view before inspection
Auditing drives improvement in clinical research. A qualified auditor since 2013, I check that your studies protect participants’ rights and safety and produce credible data.
What I take care of
- On-site investigator site audits.
- Trial master file (TMF) and investigator site file (ISF) audits.
- Audits of dietary supplement and medical device studies (ISO 14155).
- Inspection readiness for site and sponsor teams.
- Audit report with graded findings and recommendations.
- Follow-up of corrective and preventive action plans (CAPA).
Frequently asked questions
What sponsors, CROs and sites most often ask me before a mission starts.
Can you audit a study you did not work on?
That is the rule: an audit must be independent from operational teams. I never audit a study I have worked on.
Need help with this?
Leave your details and a few words about your study: I will get back to you within 2 business days.