Quality Risk Management

Why is QRM important?

The European Medicines Agency (EMA) describes the role of QRM in its reflection paper on risk based quality management of clinical trials:
“Sponsors are expected to … move towards a more systematic and risk-based approach. There is a need to find better ways to make sure that limited resources are best targeted to address the most important issues and priorities, especially those associated with predictable or identifiable risks to the wellbeing of trial subjects and the quality of trial data and results…. Quality Risk Management has become an accepted standard. This concept can be adapted and described for clinical research with medicinal products.”