Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 2

Mitigating the Challenges of Clinical Trial Monitoring:
A Technology-Amplified Approach
The accelerated number, pace, and globalization of clinical trials today have made
trial management and monitoring far more complex and costly. On-site clinical trial
monitoring alone is estimated to account for up to 30 percent of study costs.1 As the
life science industry faces unprecedented challenges to develop new products at
a faster pace and lower costs, sponsors and clinical research organizations (CROs)
have been increasingly embracing Internet-enabled technologies, such as electronic
data capture (EDC) and fully integrated clinical trial management systems, to ensure
quality and gain needed efficiencies. EDC is used in approximately half of all
clinical trials today, and 32 percent of trial sites use Internet-based EDC.2
Given the significant investment in time, resources, and money spent on monitoring
activities, trial sponsors must make sure their CROs are using the best, most efficient
methods for study oversight and quality assurance. Today, many companies continue
to utilize a traditional 100 percent source data verification (SDV) on-site monitoring
model. Sometimes a reduced SDV approach and targeted monitoring techniques are
used, but not in the context of a robust, risk-based monitoring approach with a risk
assessment/mitigation plan. Small and mid-sized life sciences companies and CROs
typically lack the technological advances for such an approach. Without real-time,

In a recent trial where
Clinipace implemented
a risk-based, just-in-time
monitoring approach,
the sponsor estimated a
% savings in
the cost of
monitoring
the trial —more than
$1M in operational costs.

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fully integrated data, the ability to assess and analyze risk is limited.
In this challenging environment, trial sponsors of all sizes have been increasingly
turning to digital CROs (dCRO) with advanced clinical trial management and
monitoring systems, and leveraging these technologies more fully to oversee trial
performance in real time. Increased adoption of technology and improved clinical
operations processes have redefined the role of clinical monitoring while increasing
efficiencies and improving the quality of data and clinical trial conduct.

clinipace.com

1