Course Description

This web seminar is designed for sponsor/CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. The current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial. Feasibility questionnaires and the current process are often not effective in predicting site success in implementing a given clinical trial. This session will explore novel approaches and technologies that can be used to significantly improve the feasibility assessment process at the protocol, country, and site level.

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Learning Objectives

• Evaluate the traditional approach to study feasibility assessment
• Examine what’s working, what’s not, and why not
• Re-define the concepts of study feasibility at the protocol, country and site level
• Discuss the purpose and objectives for conducting feasibility assessments
• Explore paradigm shifts in the approach and methods for evaluating study feasibility
• Examine a live demonstration of several new methods, technologies, and approaches
• Identify the characteristics of a high-enrolling site for a given study
• Identify how a protocol can be optimized for enrollment and how the sponsor can maximize enrollment at each site
• Employ practical, statistical, and simulation based methods for country allocation and site selection practices

Who Should Attend

• Directors of Clinical Operations
• Regional Medical Directors
• Clinical Project Managers
• Site Selection Specialists
• Clinical Research Associates
• Clinical Research Associate Managers

Instructor

The course will be led by one of the following instructors:

Beth D. Harper, B.S., M.B.A.

Click here for complete trainer biographies

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.