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.