Our quality management in clinical trials helps to ensure that:
- Procedures in force are standarised,
- Regulatory and legal requirements are followed,
- Customer expectations are met
- Products are safe and reliable and
- Sites are run in organized and efficient manner.
The primary objectives of GCP quality audits are to ensure that the rights and safety of trial subjects are respected and that the integrity of the trial data collected during course of the clinical trial can be assured. Routine GCP on-site quality audits serve to recognize 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 the study staff can then improve the general quality of the data in a significant and cost effective way.
monipol specializes in conducting GCP audits of clinical trials of phases I to IV on behalf of pharmaceutical companies, academic sponsors, CROs and non-governmental organizations.
Audits are conducted according to international standards:
1. ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline For Good Clinical Practice E6(R2), current step 4 version, dated 09 November 2016
2. ISO 19011 – Guidelines for auditing management systems,
3. ISO 9000 – Quality management systems - Fundamentals and vocabulary
4. European Network of GCP Auditors and other GCP Experts (ENGAGE) – Auditing Guideline, 2005.
monipol’s Quality Manager and GCP Auditor has 20 years’ experience in clinical trials. He performed more than 50 GCP audits as an auditor and co-auditor in Poland, Slovakia, Czech Republic, Hungary, Germany, Ukraine and Russia, in accordance with a number of international standards.
For more information on our GCP audits, please contact:
Quality Manager and GCP Auditor: