Quality Management System
Monipol International has implemented the Quality Management System in accordance with the ISO 9001:2015 standard.
All our quality assurance activities are aimed at:
- Compliance with the general requirements for the protection of study participants and data quality assurance.
- Compliance with international standards and local regulatory requirements applicable for clinical trial conduct.
- Performance of services in accordance with individual client requirements.
- Assurance of individual training for employees.
Quality Management includes:
- Systematically controlled and revised SOP system.
- GCP training of staff employed at Monipol International as well as at investigational sites.
- Audits of internal systems, clinical trials in progress, clinical trial documentation, performed internally and upon client’s request.
- Continuous quality enhancement with respect to internal processes of our company.
- GCP consultations.
- Constant monitoring and improvement of certified Quality Management System according to the ISO 9001:2015 standard.