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.