Sites Unseen: Critical Steps To Implementing Risk-Based Monitoring

By Rick Morrison, CEO, Comprehend Systems

Clinical trials sponsors are moving from 100 per cent site monitoring of research data, thereby reducing costs and saving time, and resulting in a more efficient and successful outcome. However, there are crucial strategies that should be adhered to in order to ensure a streamlined process.

Over the past year, the FDA has recommended that clinical trial sponsors move away from their reliance on full on-site monitoring of research data – an extremely time-consuming and costly process that typically involves thousands of hours of manpower per trial – and conduct more centralised and risk-based monitoring. Risk-based monitoring is both more effective and safer for patients because monitors can review smaller amounts of more focused data with greater accuracy. When implemented correctly, it can also lead to huge cost savings; sponsors can save 23 per cent of trial costs with a risk-based approach.