EFS Site Best Practices Workshop

In this workshop, sponsors, EFS sites, and regulators gathered over two days to discuss:

• Managing risk, SAEs, & IRB reporting
• Timely & Effective Contracting-Sites Achieving 60/60/60 or Better
• Budgeting between EFS Sites and Sponsors
• EFS Staffing and Resources-Patient Identification, Enrollment, & Retention
• Coverage Determinations & Site Budgets.

Throughout the workshop, Sponsors and Sites gave their perspectives of best practices for EFS clinical studies. Sponsors highlighted the importance of collaborating with the FDA to structure protocols for quick patient enrollment and conducting site qualification visits early before protocol finalizations. From the site perspective, the importance of working with highly engaged and qualified research staff, as well as collaborating with IRB, was emphasized as key points to improve the launch of an EFS clinical study.