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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 EMA (European Medicines Agency) reflection paper that encourage the drug industry to adopt risk-based monitoring techniques.

"The industry began exploring risk-based techniques after the FDA and EMA recommendations in 2011," Dr. Rosenberg said. "Health Decisions has been using risk-based monitoring techniques as an integral part of our adaptive monitoring solution for more than seven years and we have learned a great deal along the way. This article is a way to share some of what we have learned."

Adaptive monitoring is one element of Agile Clinical Development, Health Decisions' comprehensive IT-driven approach to managing and executing clinical trials. "For the drug and device industries, Agile Clinical Development provides a way to get new products to market faster and at lower cost," Dr. Rosenberg said. "For the public, Agile Clinical Development means earlier access to improved treatments and medical devices at more affordable prices."

Health Decisions won the prestigious 2013 CIO 100 Award based on its adaptive monitoring solution.  In an award winner's profile in its August 2013 issue, CIO Magazine stated that with the Health Decisions monitoring approach, "…drug and device developers benefit from better-quality data, more efficient use of resources, and substantially shorter program cycles. In some cases, Health Decisions' adaptive monitoring has reduced monitoring costs by more than 50 percent while ensuring high data quality."

About Health Decisions

Health Decisions is an industry-leading clinical research organization (CRO) and pioneer of Agile Clinical Development, providing proactive trial management based on real-time actionable information, enabling decisions that reduce timelines, accelerate access to new medicines and medical devices and allow biopharmaceutical and device companies to seize market opportunities. Founded in 1989, Health Decisions has conducted a range of successful clinical trials involving tens of thousands of patients, consistently reducing sponsors' financial risk and time to market. Health Decisions is headquartered in Durham, NC and operates on all five continents.

About The Journal of Clinical Research Best Practices

The Journal of Clinical Research Best Practices is published monthly—at no charge to over 100,000 subscribers—by First Clinical Research LLC, which also offers comprehensive resources on clinical research, including free industry directories, glossaries, and searchable databases.  Managing Director Norman Goldfarb is a leading authority on clinical research best practices, Editor of The Journal of Clinical Research Best Practices, and Chairman of Model Agreements & Guidelines International (MAGI), which is streamlining clinical research by standardizing best practices for clinical operations, business and regulatory compliance.

First Clinical Research LLC
Norman Goldfarb
Managing Director
+1 650.465.0119
ngoldfarb@firstclinical.com

Media Contact: Leslie Hammill, Health Decisions, 9199671111 ext. 520, lhammill@healthdec.com

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