ITREAS operates a Quality System that ensures compliance with the Good Clinical Practice guideline (CPMP/ICH/135/95) and all applicable legislation, directives and regulatory requirements.
Through our Quality System, we aim to provide and ensure quality at all levels:
Achievement of these aims involves all staff, partners and subcontractors of ITREAS working to the highest standards of service, resulting in a constantly improving work environment for all stakeholders.
Compliance with the Quality System and its Standard Operating Procedures is continually evaluated through quality controls and audits, both on a study and system level. The Quality System is revised regularly, at least every two years, to ensure that it reflects the organizational design, work processes, services and quality assurance processes of ITREAS, and that it remains compliant with the latest developments of Quality Assurance in clinical research.
ITREAS’ Quality System has been built and is maintained by Profess Medical Consultancy B.V., a leading consulting organization on the design and maintenance of Quality Systems for healthcare organizations, and specialized in ICH GCP and Clinical Quality Assurance Auditing of sites, laboratories, institutes and hospitals.