Challenge: 

• Not only had the Sponsor never conducted such a large trial before, but they wanted to complete this one in 1/3 of the time of similar trials. A direct-to-patient campaign generated leads, but all participant information was self-reported, making it difficult to determine if participants met the inclusion/exclusion criteria. All self-reported information had to be verified by medical records.

Goal:

• Accelerated enrollment 
• High patient retention

Solution:

Elligo accelerated enrollment and protected data quality with innovative solutions:

• Partnered with sponsor selected recruitment vendor to generate leads and make sure participant data was captured properly
• Handled patients record outreach, gathered the necessary health information from widespread sources, and thoroughly analyzed it to proactively eliminate new patients’ exclusion problems
• Took full responsibility over trial data management, providing expert quality control and real-time oversight
• Elligo’s central principal investigator oversaw the process and ensured compliance, while our project manager managed the trial by the client’s side

Results:

• Enrolled 14,215 patients, exceeding the initial goal of 12,200
• Completed enrollment in one year, which often takes similar trials two or three years to achieve
• Mitigated challenges through our expert oversight to keep the study on time and on budget