Clinical Protocol Development

Venue: Le Meridien

Location: Cambridge, Massachusetts, United States

Event Date/Time: Oct 09, 2012 End Date/Time: Oct 10, 2012
Early Registration Date: Sep 07, 2012
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Knowing how to effectively develop a clinical trial protocol is essential to a compound achieving IRB approval, ensuring the success of the study and ultimately achieving market approval, and there is much variability between companies and individuals on how to optimally approach the development of this critical document. At Barnett International & Cambridge Healthtech Institute's Second Annual Clinical Protocol Development Conference , stakeholders in the protocol development, clinical operations and compliance arenas will come together to discuss strategies to optimize the overall protocol development process.

Featured presentations include:

Protocol Complexity and the Results of a New Study on the Economic Impact of Unused Protocol Data with Ken Getz, Senior Research Fellow, Assistant Professor, Tufts Center for the Study of Drug Development, Tufts University Medical School

Post-Mortem Analyses and Lessons Learned for Avoiding Amendments: A Case Study with Beth Harper, President, Clinical Performance Partners, Inc. and Jane Fang, M.D., M.S., Associate Director, Clinical Informatics, MedImmune

Writing the Protocol to Achieve the Best Study Outcomes: Linking Objectives to Endpoints with Nariman A. Nasser, CCRP, Director, UCSF Participant Recruitment Service, Clinical & Translational Science Institute University of California, San Francisco

Phone Screen Analytics for Sites with Justin W. Withers, Director, Clinical Operations, DermResearch, Inc.

Navigating Personal Agendas to Facilitate
Protocol Development with Cheryl Vitow, President, Medical Writing, CliniQuill Associates, LLC

Also taking place at the summit are three timely programs on Virtual Investigator Meeting Management, Clinical Project Management and Clinical Training and new for 2012, four tactical short courses on Writing Successful Clinical Protocols, Problem Analysis Method Overview, Proactive Approaches to Vendor Management, and Design Considerations for GCP Training Programs.

For event updates and to register, visit (