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Health Decisions CEO Michael Rosenberg, MD, MPH, Offers Insights into Adaptive and Risk-Based Monitoring in the Journal of Clinical Research Best Practices
Date:9/3/2013

DURHAM, North Carolina, Sept. 3, 2013 /PRNewswire-iReach/ -- In an article appearing today in the Journal of Clinical Research Best Practices, Health Decisions' CEO Michael Rosenberg, MD, MPH, explains why continuous midcourse adjustments in monitoring are even more important than the initial monitoring plan in ensuring data quality and maximizing efficiency in clinical trials.

(Photo: http://photos.prnewswire.com/prnh/20130903/MN72794)

"A sound initial monitoring plan is essential for effective risk-based monitoring but it is only a starting point," Dr. Rosenberg said. "Rapidly adapting during the trial determines the effectiveness of monitoring and that requires streaming data from the field and systems that transform that data into actionable information. Few trial management systems are up to the task." Risk-based monitoring increases efficiency by focusing monitoring resources on the data that is most important to the success of a trial.

"If 100% source data verification is the first generation and risk-based monitoring the second generation, Dr. Rosenberg's system of 'Agile Clinical Development' is probably the fourth generation—and it's operating today," stated Norman M. Goldfarb, Editor of the Journal of Clinical Research Best Practices. Our mission is to advance the practice of clinical research and Dr. Rosenberg's insights into the future of risk-based monitoring do exactly that."

In "Adaptive Monitoring: Risk-Based Monitoring and Beyond," Dr. Rosenberg assesses the state of trial monitoring as the industry responds to an  FDA guidance document and

SOURCE Health Decisions
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