Quality Assurance

Quality_Assurance_CRO_pharmaCROS NT has an independent Quality Assurance department which maintains a quality system that ensures clinical operations compliance and 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.

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.

CROS NT Srl is ISO 9001:2015 certified.