Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 10

The earlier remote QA auditing capability can occur in the process, the
better informed QA is as to which sites/monitors to select for focused
on-site QA audits, prioritizing those aspects of an audit that must be
done on site compared with the greater amount of compliance data
now available remotely to the auditor. With a more proactive audit
capability, QA findings are fed back to the project team at a much earlier
step in the process. Changes to the monitoring plan may be necessary,
based on identified areas of risk. Corrective and preventative actions
are identified and taken promptly, thereby mitigating the scope and
significance of identified noncompliance issues.
With an integrated monitoring system, the trial monitor and QA
representative can gather considerable information remotely prior to
the start of the trial. QA, for example, can check if IRB approval and
other required study documentation are present in the electronic TMF
to allow investigational product release. The monitor can set up the site
remotely, and schedule an early site visit to check if informed consent
and the correct version of protocol have been approved, and compare
patient information in the database with patient medical records.
Ensuring clean, high-quality, compliant data on which the FDA
and other agencies, healthcare providers and consumers can rely
depends on the expertise of the clinical trial team and effectiveness
and efficiency of the systems and processes used. The integration
of trial processes and robust technology-amplified data validation
enhance quality control and minimize project risk. An integrated
software system can continually track the quality of trials during their

“Patient enrollment is one of the
biggest challenges we face when
starting an oncology trial… We
(are) able to monitor our studies
to ensure they are on track right
from the start, specifically, the
number of patients enrolled at
each of our sites, as well as factors
that impact enrollment and
protocol compliance. With the
ability to monitor these critical
areas in real-time, the study
teams have the ability to adjust
patient enrollment strategies with
improved data quality.”
–  odd Butler, Director Clinical
T
Operations, Prometheus
Laboratories

execution and across trials. Compliant electronic records are always
readily available for analysis. The efficient use of advanced digital trial
monitoring services ensures that study conduct occurs according to
protocol while following GCP guidelines and regulations.

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