Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 11

The transparency of systems and processes that underlie quality control
helps instill regulator and healthcare provider confidence in clinical
trial data. In accessing the trial metadata, stakeholders can see how
standard operating procedures (SOPs) were operationalized in the
trial. Integrating clinical trial data and metadata within a single system

Digital Trial Monitoring Benefits:

delivers a more comprehensive picture of the overall trial conduct. The
use of technology both enhances quality control and makes evidence of

1.  inimized project risk
M
through increased quality
control

that control easily manifest.

2.   ncreased confidence in
I
clinical trial data

easily enable revisions without generating a time-consuming query.

3.  omprehensive view of
C
overall trial conduct

immediate feedback mechanism, and eliminate queries. Documenting

4.   ncreased speed of data
I
query corrections

that would be a protocol violation.

5.  ase of documented protocol
E
compliance

Greater reliance on integrated monitoring technology can improve

Another advantage of most digital systems is that they immediately alert
site staff and monitors when information is entered erroneously and
The system speeds the generation, resolution and tracking of queries by
enabling site staff to easily make data corrections online, based on the
protocol compliance is also easier with digital technology, as welldesigned electronic case report forms (eCRFs) prevent the entry of data

Improving Relationships and Business Value »
CRO, sponsor and site team relationships. Clinical monitors with
immediate access to data can function more as coaches to study sites
rather than as inspectors.
CROs that can share trial and process data in real time, both internally
and with sponsors, can perform proactive trial monitoring and work
collaboratively for better understanding, control of variability, and
troubleshooting.

clinipace.com

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