Health Decisions CEO Explores Adaptive Monitoring Techniques for Late-Stage Clinical Studies in June 14 DIA Session

Dr. Michael Rosenberg will describe how fast access to metrics, flexible processes, and automated technology enable study monitors to increase efficiency

Health Decisions 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.

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.

For media information or to arrange a meeting with Dr. Rosenberg at DIA please contact Courtney Cleaves, Marketing Manager at ccleaves@healthdec.com.

Michael Rosenberg

“Applied to site management, adaptive methodology empowers monitors to be more than just box-checkers. 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.”

Dr. Rosenberg
Founder and CEO
Health Decisions

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