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A well designed protocol is the foundation for on-time
enrolment. Once enrolments starts, clinical trial monitoring sets in to have
the data delivered on-time. As a rule, a significant proportion of the overall
budget is devoted to clinical trial monitoring and since so much money is spent
here, what are vital elements of clinical trial monitoring to achieve quality
data?
Well organized and dedicated teams that understand the
common goal. A clinical project manager should have the skills to team-up with
the sponsors and thoroughly understand the sponsor needs to guide the clinical
research associates in their work. Clinical project managers should not have
too many projects to care about; the same goes for clinical research
associates. Furthermore teamed-up clinical research associates will help each
other and the investigational sites out more often and even better, leading to
faster resolution of numerous issues. Without a doubt, strong and ongoing feedback
loops between sponsor, clinical project managers and clinical research
associates will speed everything up
and affect clinical trial monitoring as a whole.
Another element is not
having CROs swap clinical project managers and clinical research associates too
often from the one clinical trial to the next. This will even strengthen the
sense of responsibility and commitment of both to clinical trial monitoring
regardless of the trial. When it comes to clinical trial monitoring both
sponsors and investigator teams will know who to reach, are sure that the CRO cares
about the problem they face and simply know that a quick and adequate solution
is at hand.
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