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Clinical Protocol Development

Date: 09-Oct-12 to 10-Oct-12
Location: Le Meridien / Vienna / Austria
Category: Healthcare & Pharmaceuticals Science Conferences & Trade Fairs

Implement Strategies to Maximize Adherence, Productivity and Compliance


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
Or replace list with: In response to recent FDA activity, the conference will explore risk-based monitoring and quality management systems as they relate to clinical protocol development and site training. Avoiding costly protocol amendments will be a theme throughout, including a case study from MedImmune on post-mortem analysis, and how that analysis improved the organization’s clinical protocol design process.

Also taking place at the summit are three timely programs on Clinical Project Management, Clinical Training and Virtual Investigator Meeting Management.

For event updates and to register, visit BarnettClinicalSummit.com.

Visitors

This summit particularly benefits professionals at pharmaceutical,
biotech and medical device companies who work in:
• Clinical Trial Management
• Site Management
• Study Start-up
• Project Management
• Monitoring
• Clinical Training
• Medical Writing
• Protocol Development
• GCP Compliance
• Clinical Operations
• Budgeting
• CRA Management
• Study Site Evaluations
• Risk Management
• Outsourcing

The summit is also of interest to:
• Contract Research Organizations
• Regulatory Agencies
• Technology and Service Vendors
• Consultants

Exhibitors

Learn more about our sponsors at http://www.barnettclinicalsummit.com/bcs_content.aspx?id=105595&libID=105552

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