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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

entific_guideline/2011/08/WC500110059.pdf">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 biopharm
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