A Perspective on Risk Based Monitoring

Moving towards the development of mature quality management systems.

The need to boost education, shift culture, and embrace new technologies.

Under the new extension, FDA and CluePoints will enhance CluePoints’ SMART software to address a broader range of regulatory concerns.

A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.

Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.

Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.