Risk Based Monitoring

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Consistent with the new guidance from regulatory authorities on risk-based monitoring, monitoring strategy needs to reflect the individual needs of the study. In addition to traditional on-site monitoring, modern monitoring strategies should be leveraged, focusing on the potential risks that would affect the reliability of the study data. These include the use of targeted on-site monitoring, centralized remote monitoring, and real-time review of clinical data using statistical analysis to identify trends and outliers.

Join us as we investigate the above principles, provide 'thought leadership' on this topic, and attempt to raise awareness of the important issues.

For more information please contact Jenell Rogers on: Jenell.rogers@industryreview.com