Project Description

Taking a New Approach to Monitoring

Published in Contract Pharma, June 2010 ghost written for Mark Shapiro

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 U.S. and international agencies, clinical trial monitoring helps ensure the integrity of the data, the consistency of the science, and of course, the safety of the patient.

Today’s clinical research associate (CRA) may monitor 10 to 12 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.

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