We have an independent Quality Assurance department which maintains a quality system that ensures clinical data accuracy and integrity through a systematic and independent examination of all trial-related activities and documents. The quality management system ensures that data are recorded, analyzed and accurately reported according to Standard Operating Procedures (SOPs), ICH/GCP guidelines and EMA and FDA requirements as well as national and international laws such as GDPR.
CROS NT has Quality Assurance certifications to ensure quality, compliance and trust.
Our aim is to achieve the highest performance in clinical trials by maintaining a continual review of consistency and documentary evidence of quality throughout the drug and device development process.
Our Quality Assurance department also ensures consistency across the world. Our internal system audits, vendor audits and structured training programs enables us to avoid risks and eliminate systematic problems. We have procedures in place to guarantee disaster recovery and business continuity.
Quality Assurance Certifications
CROS NT Verona site is ISO 9001:2015 certified for its Quality Management System.
CROS NT also relies on its sister company, Arithmos Information Technology to manage its IT systems and processes as Arithmos is an ISO 27001:2014 certified company for an Information Security Management System (ISMS).