QUALITY MANAGEMENT SYSTEM
In order to deliver work to the highest quality standards, monipol maintains a Quality Management System according to ISO 9001:2015.
Through our System, we guarantee the following:
- Observance of general requirements for study participant protection and data quality assurance.
- Compliance with international standards and local regulatory requirements applicable for clinical trial conduct.
- Assurance of individual training for employees.
- Delivery towards individual client requirements.
Specifically, our Quality Management System involves:
- Systematically controlled and revised SOP system.
- GCP training for staff employed at monipol’s offices as well as at investigational sites.
- Continuous audits of systems, clinical trials in progress, clinical trial documentation performed routinely and on client request.