Challenge:

• A pharmaceutical company engaged with Elligo and a competitor for a pilot phase of its early colon cancer detection blood draw study to determine which partner would be chosen for a larger pivotal study. Additional challenges in the healthcare landscape and concerns about patient privacy caused interested participants to not proceed with the study requirements at the expected rate. Client also added new focus on enriched participant populations and goals mid-study. 

Goal: 

• Deploy full-service hybrid study conduct utilizing Elligo Central PI and diversity patient enrollment.

Solution: 

• Elligo deployed its Central PI to oversee recruitment, enrollment, mobile phlebotomy services, medical record collection, data entry, and pathology report review for 750 completed participants across the US.   When a request was received from client to diversify enrollment, Elligo pivoted to identify additional patients and ensure enrollment timelines stayed on-track.

Results:

• Achieved FPI within 4 days of greenlight
• Positive performance ultimately led to Elligo being selected by client as sole provider for prior extension phase to achieve additional 1,500 completed participants
• Close collaboration with client to maximize their established participant referrals sources and contract quickly with new funnel sources
• Quick action to revise recruitment collateral and obtain sponsor/IRB for approval allowed us to pivot on-demand to reach the breadth of diverse participants
• During final months of extension phase, selected during competitive bid process to become the sole DCT provider for client’s upcoming pivotal study