A Perspective on Risk Based Monitoring

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.

Site and project management teams play major roles in risk-management and monitoring performance.

Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.

Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.