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2019 Agenda

Friday, September 27, 1:15 to 2:00                                          

Ensuring Success Through Smarter Site Selection and 
Study Feasibility

Ensuring Success Through Smarter Site Selection and Study Feasibility

Site Selection is a complex dance between sponsors and sites. The wrong choice can have serious consequences, impacting quality, time and finances for both the sponsor and investigator. Steps for site selection and feasibility will be discussed. This session will explore best practices for both sponsors and sites during the selection process. Sponsors will learn the most critical questions to ask an investigator and staff to ensure quality and timely data as well as appropriate enrollment for the proposed clinical trial. Sites will learn how they can be proactive in the selection process and how to ensure a study is feasible by considering logistics, resources, and staffing. The whole process of site feasibility and selection will be outlined with key decision points for both sponsors and sites. Sites and sponsors will also learn what tools can help sites become “preferred” and achieve excellence in the execution of a clinical trial. 609

Presenter: Janet Ellen Holwell, BA, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant

Track: Monitoring

Friday, September 27, 2:05 to 2:50     

Checking the Eligibility Checklist

This discussion will review the eligibility checklist elements of management and review process. Recommendations to ensure that the eligibility checklist is created, used, managed, and executed properly will be provided. The importance of dedicating adequate resources to enforce proper eligibility checklist management through developing, implementing, and maintaining a real-time participant eligibility verification process, which will ensure that clinical trial registrations are conducted according to regulations, will be reviewed. Mr. Granobles will examine the importance of having an independent review  (administrative quality assurance),  aside from the study team, and systems that can be used to improve this important quality assurance process. 611

Presenter: Adrian Granobles, MS, CCRP, Clinical Research Team Lead, Monitoring, Memorial Sloan Kettering Cancer Center (MSK)

Track: Monitoring

Friday, September 27, 3:25 to 4:10                                          

 A Changing Role in a Changing Landscape - How the Role of the CRA Will Evolve in the Next 5 Years

The role of the CRA in the future is evolving to one with less on-site data verification and increased focus on consultative problem solving through data driven insights. Mr. Leray will share experiences and facilitate a discussion with the research community on how to jointly prepare for what is to come. 613

Presenter: Eric Leray, MSc, Senior Director, IQVIA

Track: Monitoring

Friday, September 27, 4:15 to 5:00                                          

Empowering Clinical Research Associates with New Mobile Tools

In 2017 Mr. Williams gathered a large working group of CRAs to brainstorm solutions for solving the many daily challenges faced by CRAs: managing study touch points, reviewing patient details, reducing administrative burdens, etc. An exciting outcome of this brainstorming session was the concept of utilizing mobile technology to improve the monitoring process. Recent advancements in technology have ushered in a new era of mobile computing including smartphones and tablets. These portable yet powerful devices truly complement clinical monitoring and the mobile nature of the clinical research associate’s role. CRAs were recently equipped with iPads and launched several applications to help CRAs manage their sites, trial participants, data, and documentation while in the field. Mr. Williams will share the impact these tools have had on CRAs, sites, and studies, and how mobile tools might be used more broadly within our industry. 615

Presenter: Brian Williams, BS, Senior Director, Mobile & Technology Solutions, IQVIA

Track: Monitoring