Effective Operational Planning for Adaptive Clinical Trials
Chicago, IL (PRWEB) June 2, 2009
ClearTrial (http://www.cleartrial.com), a leading provider of clinical trial software for clinical trial operations planning, budgeting, and outsourcing, announced today that Molly Blake-Michaels, Director, Clinical Services, will chair a panel of adaptive trial design experts on the topic of "Effective Operational Planning for Adaptive Clinical Trials" at the DIA 45th Annual Meeting. Held at the San Diego Convention Center, June 21-25, 2009, the meeting will bring together the biggest names from industry, regulatory, and academia to instruct on the issues affecting global drug discovery and development.
As adaptive clinical trials become more prevalent, their operational planning challenges often remain overlooked in the clinical development process. Adaptive trials place a far greater burden on the initial trial design, ranging from understanding the potential for changes in resource allocations and demands in areas such as biostatistics and drug supply, to the need for more accurate simulations of differing trial scenarios and their operational elements.
During this session, the panel of experts will examine these challenges and provide practical design and implementation guidelines for adaptive trials, including:
*Operational best practices for more successful adaptive trials
*Improving budgeting and forecasting accuracy
*IT considerations, including interactive voice response, electronic data capture, and upfront database design
*Impact of adaptive trial designs on drug supply
Blake-Michaels brings more than 20 years of clinical operations experience to the DIA session, with extensive experience in the strategic planning and execution of clinical development programs across a wide variety of therapeutic areas. Before joining ClearTrial, she worked for pharmaceutical companies such as Abbott Labs, Fujisawa, TAP, Hospira, and Ovation, as well as one of the largest clinical research organizations. Blake-Michaels has authored over 50 clinical study protocols that included adaptive studies, several investigator brochures and FDA briefing books, and multiple NDA summary documents. As an independent clinical research consultant, she prepared clients for FDA Advisory Committee meetings and post-acquisition portfolio reviews, and planned and managed numerous studies, including a REMS-required patient registry.
ClearTrial® is a leading provider of clinical trial software for clinical operations planning, budgeting, and outsourcing. ClearTrial's award-winning software helps pharmaceutical, biotechnology, medical device companies, and CROs expedite the clinical development process without sacrificing quality of results. The company's software products support clinical operations, resource planning, and outsourcing departments with a single solution that promotes speed and consistency, while maintaining flexibility to handle different study requirements. For more information please visit http://www.cleartrial.com.
ClearTrial® and the ClearTrial logo are registered trademarks owned by ClearTrial, LLC, which may be registered in certain jurisdictions. Any other company or product names mentioned in this release are hereby acknowledged as registered trademarks or trademarks of their respective owners.