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Risk Based Monitoring

The Solution for a Data Driven World

Risk Based Monitoring•Leverage:– mobile technology– internet infrastructure– analytic techniques

•Enables CRAs and data managers to – “mine” the data generated during

study conduct as it changes in real time.

– detect signals across the investigator sites such that they can focus on the most problematic sites.

Risk Based Monitoring

•A centralized data-driven approach to monitoring validity and data quality •CRAs can make site monitoring visits more often to those investigator sites whose data are suspect while the possibility exists for less often visits to sites with minimal issues.

Risk Based Monitoring

•Utilizing electronic source in conjunction with other technologies removes the task of source data verification•The CRA can focus on the cause of the possible data issues during the targeted monitoring visit

Risk Based Monitoring

•RBM is the state-of-art solution to monitoring investigator sites during study conduct. •It removes the silos between the CRAs and data managers •Uses the current technologies to assure the validity and quality of the data being collected while reducing the number of monitoring visits and thereby reducing costs.

Risk Based Monitoring

Please follow us as we expand on this topic and discuss the changing roles of the CRA and data manager as well as how we utilize eClinical Technology in RBM.

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