The primary objectives of GCP quality audits are to ensure that the rights and safety of trial subjects are respected and that the trial data collected during the course of the clinical trial is coherent and reliable. Routine on-site GCP quality audits serve to recognise and correct site-specific problems and can be scheduled at any time during the conduct of the clinical trial. Prompt implementation of corrective/preventive actions by staff can significantly improve the general quality of the clinical trial.
Monipol International specialises in conducting GCP audits of phase I to IV clinical trials.
Audits are conducted according to international standards: Guideline For Good Clinical Practice E6(R2), ISO 19011, ISO 9000 and ENGAGE.
Our Quality Manager and GCP Auditor has 20 years of experience in clinical trials. He has performed approximately 50 GCP audits as an auditor and co-auditor in Poland, Slovakia, Czech Republic, Hungary, Germany, the Ukraine and Russia.
Quality Manager and GCP Auditor: