Clinical trial enrollment delays are common and can lead to increased study costs and extended time to market. A formal feasibility performed early in the development process can guide the project team through scenario planning that allows for more accurate planning.

By combining study-specific information collected through surveys or interviews with historical data from prior studies and other data sources, teams are able to make more informed enrollment projections that can aid in operational planning. These enrollment projections should then be combined with other relevant data such as insurance reimbursement, the regulatory environment, enthusiasm for the study therapy, regional differences or shifts in patterns of care and potential operational challenges to make country- and site-level recommendations. This presentation focuses on the steps of proper planning through a robust feasibility assessment to guide successful clinical trial completion.

This audio conference covers:

• Defining the goals of your feasibility assessment – protocol or site-level data
• Establishing the timelines to ensure that data is available prior to study start-up
• More than just a survey: components of a robust feasibility assessment
• Interpreting the information and using it to guide your decision-making

About the speaker:

Kim Nelson is Director of Global Feasibility Strategy at PPD, a CRO with 25-years of excellence in driving execution, quality and innovation through its 10,500 professionals in over 41 countries. She has 25 years of experience in global drug development including clinical program development, project management, and development of risk management and market optimization programs. Ms. Nelson has worked at biotechnology, pharmaceutical, consulting, and contract research companies. She utilizes this comprehensive knowledge of various aspects of drug development and works closely with local clinical management teams to guide PPD’s collaborators in strategic assessment of a clinical trial or clinical program’s feasibility.

Who should attend?

• Clinical Operations
• Project Management
• Feasibility
• Clinical Development