Hi,
AI, analytics and data mining is used in risk-based quality management during clinical trials. A good introduction to the topic is given here :
https://www.amazon.com/Risk-Based-Monitoring-Detection-Clinical-Trials/dp/1612909914
Pharmaceutical companies create a series of risk indicators that will ensure timely monitoring of data quality - this could be as simple as a lab instrument that is not calibrated or complex interactions between clinical sites and the recruited patients. The goal is to ensure that the data integrity is being maintained for submission, safety and overall quality purposes.
This procedure is in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). Available at: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.
Best regards,
Mark
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