Challenge:

• Low performing sites: Sponsor frustrated with initially selected low/no enrolling sites, leading to low delivery confidence
• Poor screening and retention: Known side effects and required lab values at screening drove high screen fail and early termination rates
• Quick timeline: <6-month window from Elligo’s selection to Last Patient In, including winter holidays

Goal:

• High volume enrollment
• Retention of patients in GLP-1 trial

Solution:

• Used Elligo central coordination to support quality delivery of accelerated enrollment
• Fully dedicated central research MD promptly addressed site and coordinator prescreening questions, bypassing delays and relieving local investigators
• Planned for variance between the ‘with’ and the ‘without T2DM’ screening and enrollment rates
• Invested in patient retention with support such as access to licensed dieticians
• Vet patients with motivation + barriers assessment at screening to drive higher retention
• Fast Start-up –single contract with Elligo (vs CTA with each Elligo integrated PI/site)

Results:

• Enrollment progressed consistently ahead of projected rates
• Early termination rate distinctly lower for Elligo sites than overall study rate
• CTA signed to site work orders signed in 1 week, with award to FPI in 8 weeks