Challenges:

• Timeline: The FPI was at risk due to sponsor delays in approving the launch of the creative materials developed by third-party vendor.
• Logistics Coordination: Coordinating blood draws and colonoscopies was challenging, with regional coverage gaps and a 2-week delay between screening and blood draw causing patient loss.

Goal:

• Enroll 750 patients within 3 months using a decentralized model (DCT).

Solution:

• Elligo’s Clinical Research Center (CRC) and Patient Engagement (PE) Team launched impromptu grassroots campaigns and cold calls ahead of the third-party vendor, quickly developed branding, secured IRB approval, and onboarded two PE Specialists within 2 weeks to identify and contact > 500 patients.
• Switched mobile phlebotomy vendors to improve blood draw and colonoscopy coordination and expand regional footprint.
• The Central PI provided oversight for quality control: medical adjudication of colonoscopy reports to ensure accurate diagnosis and proper follow-up care; management of patient eligibility and consenting; and adverse event reporting.

Results:

• Elligo met FPI goals despite initial delays, using our Patient Engagement team and Elligo CRC site staff. 
• Exceeded initial enrollment target within the 3-month timeline, while maintaining high quality, volume, and achieving diversity goals. 
• Elligo was awarded an extension of the study with double the patient target.