John Michaloudis

Clinical trials are becoming more complex, more data-driven, and more reliant on technology. At the same time, regulators expect sponsors to apply a proportionate, risk-based approach to trial quality, oversight, and decision-making. That is where RBQM clinical trial software comes in. Risk-Based Quality Management, or RBQM, is no longer just about reducing source data verification […]

  What is Risk-Based Quality Management or RBQM? RBQM is, at its core, a structured and proportionate way of managing trial quality by focusing attention on the factors that matter most. Historically, risk-based approaches in clinical trials were often reduced to monitoring techniques. Over time, that evolved into a broader RBQM framework, where risk-based monitoring […]

In our previous issue, we looked at risk evaluation: how identified risks can be assessed more meaningfully by considering likelihood, impact, detectability, and the controls already in place. That step helps teams understand which risks are more significant in the context of the trial. But once that evaluation has been done, the next question is […]