You are on page 1of 1

Health Decisions CEO to Explore the Role of Clinical Operations in Adaptive Rese arch at Adaptive Designs Summit, April

29 Michael Rosenberg, founder of adaptive-focused CRO, will discuss how flexible cl inical operations support the new FDA Draft Guidance on adaptive design. Durham, NC, April 26, 2010 -- 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 applie s adaptive principles to both design and operationsâ at Adaptive Designs for Clinic al Drug Development, to be held April 28-30 in Philadelphia, PA. The Summit will focus solely on adaptive clinical development, providing an oppo rtunity for FDA members and research experts to determine the impact of the rece ntly 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: Rea lizing the benefits of a fully adaptive clinical program (one which utilizes ada ptive methodology to improve both design and operations) Overcoming the four maj or clinical bottlenecks: enrollment, query management, monitoring costs and data base lock Assessing the technology systems required to implement fully adaptive programs Reducing risk, cost and timelines: how adaptive methods effect net pres ent value (NPV), internal rate of return (IRR) and the healthcare crisis. According to Dr. Rosenberg, applying the adaptive thought process to clinical op erations presents an immediately actionable, universally beneficial solution wit h potential to drastically improve standards of efficiency in drug development. "Adaptive operations dramatically boost the timeliness and reliability of adapti ve 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 o f adaptive methodology while becoming accustomed to the growing acceptance of de sign-specific adaptive techniques." "Bigger Picture Adaptive: Improving Success Through Advanced Operations" takes place Thursday, April 29 at 11:15 a.m. EDT at The Ritz Carlton Philadelphia in Philadelphia, PA. To view the Adaptive Designs for Clinical Drug Development brochure, please visi t the event website ( For more information, please contact Kate Hendrick, Marketing Specialist, by ema il at or by phone at +1.919.967.1111 x116. Contact: Kate Hendrick Marketing Specialist Health Decisions Inc Durham, NC +1.919.967.1111 x116