Simplifying Risk-Based Monitoring

A few years have elapsed since ICH added the E6 (R2) addendum to its Good Clinical Practice Guidelines. Amongst other things, the revision was made to mandate adoption of quality risk evaluation & management methodologies in clinical trial design, execution and oversight.

We at Clinscience have a traffic light system where risk is characterised dynamically in red, amber and green from: study design; study protocol requirements; datapoints; site selection; site performance; document management; data quality and CRO and sponsor study governance at all levels.

We work cross-functionally to create a training data set based on existing knowledge. This knowledge is then embedded in every aspect of study design, planning, execution and oversight. As the study progresses the risk characterisation is proactively reviewed and updated. Any item requiring attention is actioned promptly and comprehensively. The ultimate aim is to execute a programme with operational, scientific, medical, clincial and data science excellence.

Contact us at to find out how we are supporting our sponsors with their pivotal (and non-pivotal) programmes.

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