The only global Standard for Clinical Research Site quality and safety is the SASI-QMS:2023-2.
It is grounded in GCP and focused on QM fundamentals. It creates a culture of competence and conscience
with a reliable quality management system that delivers high-quality trial data.
• Modeling the values and skills of a high-performing site work culture
• Increasing awareness and practice of safety and patient centricity
• Reducing waste and inefficiencies in clinical research processes
• Improving risk-based QM decision points and mitigation actions
• Stabilizing the work culture and reducing turnover