A large pharma Sponsor approached QPS to jump into a trial early and complete initial phases of recruitment and enrollment into a large, multi-cohort clinical trial. This case study outlines the challenges we faced and the solutions we put in place to deliver the study successfully.
Challenge
Initially the Sponsor contracted QPS to recruit and enroll Cohort 3 and beyond. Cohorts 1 and 2 were contracted with other sites However, when it became obvious that those sites were failing in their recruitment and enrollment efforts, the Sponsor quickly shifted their approach and asked QPS to enroll Cohort 1 and 2, starting immediately.
Solution - 3 Factors for Success
Flexible Team:
- The QPS site had not yet received IRB approval, as Cohort 3 was not due to start for some time.
- Within 2 weeks, the team quickly prepared the study package, called an emergency meeting of the IRB and secured IRB approval to start. The study was up and running shortly thereafter.
Efficient Recruitment Process:
- QPS supplemented our usual robust Call Center Team with a team of contract representatives to ensure that we could quickly reach potential study subjects, and never miss a chance to speak “live” to a caller.
Phase I Study Expertise:
- QPS successfully delivers a large number of multi-site, multicohort clinical trials on an annual basis.
- Our satellite model enables QPS to quickly pivot around Sponsor needs, working as one of many sites or running the entire trial at just one of our many sites spread across the USA, Europe, India and Asia.
Outcome
QPS exceeded the Sponsor’s expectations, pivoting quickly to secure IRB approval within 2 weeks, launching the study and recruiting/enrolling the additional 2 cohorts in timely manner.
