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Health Decisions (Booth 929), a full-service clinical research organization (CRO) specializing in high-efficiency adaptive solutions, announces that CEO Michael Rosenberg, MD, MPH will join a panel June 14 at the DIA Annual Meeting in Washington, DC. "Centralized Monitoring: When Does It Make Sense?" will focus on the advantages and requirements of monitoring programs that balance the needs of sponsor companies and investigative sites in phase IIIb to postmarket clinical studies.
According to Dr. Rosenberg, a centralized monitoring system should be based on the same general principle as adaptive design, a hot topic in the industry. Adaptive monitoring involves capturing and presenting site performance metrics to study monitors in near-real time, allowing monitors to make mid-course adjustments to study operations based on current information. This enables decision-makers to optimize site activity on a rolling and continuous basis for dramatic aggregate time- and cost-savings.
“Applied to site management, adaptive methodology empowers monitors to be more than just box-checkers,” said Dr. Rosenberg. “Each team member has the training and tools to improve site performance. When the whole team is thinking critically about the overall health of the study, you get better quality data and faster execution at every stage, from start-up and enrollment through database lock and submission."
"Centralized Monitoring: When Does It Make Sense?" will explore monitoring solutions that provide economies of scale, allocate resources efficiently, optimize every aspect of operations, and alleviate sponsors’ concerns about budget and timelines. Such solutions include:
· Need-based monitoring visits: how to reliably and efficiently determine when to dispatch monitors to sites;
· Managing based on performance metrics: which metrics to look for, how to track and report trends, and what actions to take when opportunities to improve efficiency are indicated;
· Automated data capture and processing tools;
· Electronic data as source documents.
The session will be chaired by Ramita Tandon, MPH, MSc, senior director, project management, per-approval services (PACE) at PAREXEL International. The session is part of the Clinical Research and Development/Clinical Supplies (CR/CS) track, and takes place June 14 from 3:30 – 5:00 p.m. EDT in Room 145B.
About Health Decisions
Health Decisions (HealthDec.com) is a global clinical research organization (CRO) committed to helping drug and device companies achieve greater success. Our sponsors rely on us to help them prove the value of their pipelines both faster and with the smartest possible allocation of funds. Through Agile Clinical Development—a strategic combination of adaptive design and adaptive operations—Health Decisions optimizes every facet of clinical research from design protocol to the most detailed day-to-day management, so sponsors can make the most of competitive market opportunities.
Health Decisions is headquartered in Durham, NC, with over twenty years of experience helping sponsors achieve success in Phase I-IV trials across all major therapy areas. For more information, please visit the company's website at the link accompanying this press release.
About the DIA Annual Meeting
Hosted by the Drug Information Association, the DIA 46th Annual Meeting takes place June 13 – 17, 2010 at the Walter E. Washington Convention Center, Washington, DC. The DIA Annual Meeting is the biopharmaceutical industry's largest, longest running, best-value, global, multidisciplinary event. To learn more, visit DIA online.
About the Drug Information Association (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 industry, academia, and regulatory professionals involved in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
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