JustinTime: Taking a New Approach to Monitoring
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JustinTime: Taking a New Approach to Monitoring
Careful monitoring is a necessary and important part of any clinical trial – so necessary and important, in
fact, that it has changed very little over the history of conducting clinical trials. Required by both US and
international agencies, clinical trial monitoring helps ensure the integrity of the data, the consistency of
the science, and the safety of the patient.
Today’s clinical research associate (CRA) may monitor 3 to 5 concurrent studies, with all the associated
travel, management and reporting responsibilities. Burnout is a constant problem as CRAs endure
separations from their homes and families while fulfilling their professional responsibilities at multiple
sites. It can be a challenge for clinical research organizations (CROs) to retain trial monitors due to the
demands of the job.
However, improved technology adoption and clinical operations processes are now making it possible to
redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing
clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just‐in‐Time
Monitoring that is dramatically changing the way we interact with our trial sites.
5 key reasons to make the move to JustinTime Monitoring
1.
2.
3.
4.
5.
Detecting and addressing problems early
Strengthening relationships with trial sites
Reducing the costs of conducting trials
Focusing on Ethics and Regulatory Compliance
Avoiding CRA stress and burnout
Traditional Monitoring is
like Major Surgery
Most clinical trials receive monitoring
visits about every 8 to 10 weeks. The
CRA usually has a detailed checklist of
items to evaluate, and must then
submit a report back to the sponsor
regarding the site’s performance in
carrying out the trial and protecting
patient well‐being. Unfortunately, a site monitor’s visit to collect this information can often be
disruptive and potentially inaccurate, since it only reflects a brief snapshot of the overall study. As
investigators and research staff scramble to provide information needed by the CRA, clinical aspects of
the study may be put on the back burner temporarily. This may slow or skew study results, or even
impact patient care.
Lead Monitor at Clinipace Worldwide, Carla Radke offers this analogy, “Traditional site monitoring is like
major exploratory surgery, where the patient is opened up from stem to stern to look for problems. It
causes serious disruption while trying to find a faulty system or a disease process, with the possibility of
missing more subtle clues to the patient’s health.”
Minimally Invasive Monitoring
Much as surgeries have become less invasive with the use of remotely driven cameras and laparoscopic
devices, just‐in‐time monitoring of clinical trials can also be far less invasive and disruptive.
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