Quality Assurance Consulting
QUADRO CRO Trial Team and Management Staff operates according to nearly 30 SOPs to ensure top quality, as well as ongoing quality improvement, in project management and other activities, according to ICH/GCP and local regulatory requirements. SOP updates according to a predefined revision schedule are performed by a team of experts at QUADRO CRO.
- SOP compliance
- ICH / GCP audits
- Co-monitoring / Site inspections
- Office inspections
- Trial Master File and Site File Audits
- Inventory checks of study supplies
- Training needs
- Protocol and Informed Consent Form review
- Database audits
- Inspection of Investigational Product storage, dispensing, use, destruction etc. processes
- Inspection of Trial Documentation archiving processes etc.