Release date: 2010-04-23

Health Decisions CEO to Explore the Role of Operations in Adaptive Clinical Research at FDA Summit

(Newswire Today) —  Durham, NC, United States, 2010-04-23 - Michael Rosenberg, founder of adaptive-focused CRO, will discuss how flexible clinical operations support the new FDA Draft Guidance on adaptive design April 29 at the Adaptive Designs Summit.


Michael Rosenberg, founder and CEO of full-service clinical research organization (CRO) Health Decisions, will explore the implications of a fully adaptive clinical program—one which applies adaptive principles to both design and operations—at Adaptive Designs for Clinical Drug Development, to be held April 28 – 30 in Philadelphia, PA. The Summit will focus solely on adaptive clinical development, providing an opportunity for FDA members and research experts to determine the impact of the recently released FDA guidelines on the topic.

Dr. Rosenberg will address the Summit April 29 with a presentation titled "Bigger Picture Adaptive: Improving Success Through Advanced Operations." The session will cover the following topics:

• Realizing the benefits of a fully adaptive clinical program (one which utilizes adaptive methodology to improve both design and operations);
• Overcoming the four major clinical bottlenecks: enrollment, query management, monitoring costs and database lock;
• Assessing the technology systems required to implement fully adaptive programs;
• Reducing risk, cost and timelines: how adaptive methods effect net present value (NPV), internal rate of return (IRR) and the healthcare crisis.

According to Dr. Rosenberg, applying the adaptive thought process to clinical operations presents an immediately actionable, universally beneficial solution with potential to drastically improve standards of efficiency in drug development. “Adaptive operations dramatically boost the timeliness and reliability of adaptive design components, but they also offer stand-alone value,” he said. “They can improve success for clinical trials of all sizes, scopes and therapeutic areas, and are an ideal way for the industry to familiarize itself with the benefits of adaptive methodology while becoming accustomed to the growing acceptance of design-specific adaptive techniques.”

"Bigger Picture Adaptive: Improving Success Through Advanced Operations" takes place Thursday, April 29 at 11:15 am. EDT at The Ritz Carlton Philadelphia in Philadelphia, PA.

About Health Decisions
Health Decisions ( 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 accompanying URL.

About Adaptive Designs for Clinical Drug Development
Following the much anticipated release of FDA’s Draft Guidance, Adaptive Designs for Clinical Drug Development will cover regulatory updates and issues, the latest adaptive innovations and methodologies, case studies, and lessons learned from real life adaptive implementation. The event will also address challenges faced with respect to company-wide communication and awareness and drug supply and management associated with adaptive clinical trials. The 2010 Summit will take place April 28 – 30 at The Ritz Carlton Philadelphia in Philadelphia, PA.


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