Risk Based Monitoring

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Risk Based Monitoring
The Solution for a Data Driven World

2. 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.

3. 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.

4. 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

5. 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.

6. 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.
www.quartesian.com

7. 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.
www.quartesian.com