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Sunday Afternoon, February 6, 2011
CONFERENCE WORKSHOP HOSTED BY CENTERWATCH*:
How to Accelerate Site Selection, Study Activation, and Patient Recruitment for Faster Clinical Trials
This workshop focuses on strategies, processes and tactics for starting and managing a clinical trial. From protocol feasibility, site identification and IRB processes to online patient recruitment, attendees will learn how to improve their opportunities for meeting study needs and deadlines. Specifically, the workshop focuses on the following critical areas:
Study Planning and Site Selection: How to Use Metrics to Plan Faster Trials and Find Sites with the Most Patients IRB Review: Working with IRBs: How to Create Efficiencies and Avoid Pitfalls Patient Recruitment: Leveraging Online Resources to Enhance Patient Recruitment Rates
*Separate registration required
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Regulatory Challenges and Expectations in Emerging Markets to Effective Clinical Trial Development
Jerry Stewart, Regulatory Policy Head, Emerging Markets, Pfizer, Inc.
FDA Inspections of Clinical Research Sites
Michelle Noe, Senior Regulatory Operations Officer, Office of Regulatory Affairs, US Food and Drug Administration
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Lessons Learned from Regional and Country Leads: How to Achieve Effective Monitoring and Regulatory Compliance in Emerging Regions
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Strategies For Successful Site Selection: How to Pick the Right Sites and Reduce the Percentage of Zero Enrolling Sites
Nye Pelton, CPC (Clinical Portfolio Consultant-Enrollment), US Medical Division - Oncology, Eli Lilly
Building Quality into the Site Selection Process
Mark Ridge, M.B.A., Senior Director, Global Business Operations, Pfizer, Inc.
Site Selection and Study Planning for Emerging and Poverty Related Diseases
Dr. Gabriele Pohlig, Project Leader, Clinical Research Scientist, QA Manager, Medicines Research, Swiss Tropical and Public Health Institute
Site Selection of Global Phase I Units
Erica Elefant, Senior Clinical Scientist, Discovery Medicine Clinical Pharmacology, Bristol-Myers Squibb
The Global Site Feasibility Process: Cost-Effective Techniques for Finding High Performing Sites
Adam Ruskin, M.P.H., Ph.D., Director, Clinical Operations, Emergent Biosolutions
Leveraging Internal and External Resources to Find the Right Sites
Richard Robinson, Assistant Director, Internal Medicine, Metabolism, and Diabetes Group, US-CRU, Clinical Development, Sanofi-Aventis
You Say Tomato, I Say Feasibility
Peter DiBiaso, Senior Director, Clinical Planning & Performance, Clinical Development Operations, Vertex Pharma
Linking Sponsors, Service Providers and Investigative Sites and Positioning Sites for Success by Anticipating Their Needs
Speaker to be Announced
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Site Study Coordinator Perspective: What do Sites Need from Sponsors?
How is feasibility done and what data is used by sites? What type of recruitment support is needed from sponsors? What attributes of a study make it attractive and most likely to be selected by a site? How can sponsors help sites through the approval process? What would an actual ‘wish list’ for a sponsor look like?
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