Out performing Enrollment Targets By 2x

Background

Stiris was engaged by a pharmaceutical company to take over the Canadian portion of a Global study with sites in Canada and Europe. This was originally the responsibility of a global CRO but patient enrollment targets in Canada were not being met and enrollment was a year behind schedule. The original study targets were based on competitive enrollment with Canada expected to enroll 21% of patients.

Challenge: To meet original recruitment timelines despite time lost

  • Stiris still needed to meet the original enrollment timelines.
    Sites were withdrawing from the study due to damaged relationships.

Solution: Experienced team with a Site-Focused Approach

  • Stiris took on full clinical trial management responsibility for Canada.
  • Stiris assembled an experienced team from the PM to the CRA’s to review previous enrollment issues, plan a recruitment strategy and re-build damaged site relationships.
  • Stiris held introduction visits, with protocol re-training at all sites to re-establish relationships and for Stiris to help understand enrollment issues and provide strategies/solutions to help sites prioritize this study.
  • Stiris increased the number of Canadian sites, activating new high-performing sites with whom Stiris had existing good relationships.
  • Additionally, when one of the top enrolling sites lost their primary coordinator, Stiris facilitated rapid training of the new coordinator to ensure consistent site performance.

Results:

  • Due to Stiris’ existing site relationships and our CRAs site-focused approach, Stiris successfully engaged both new and existing Canadian sites in the Sponsor’s protocol.
  • Canadian sites ultimately enrolled 48% of the total patients, more than double the Sponsor’s original target and the Sponsor was able to close enrollment a month ahead of schedule.
  • The increased enrollment more than doubled the original work load and required Stiris to add an additional CRA at short notice. This rapid team expansion ensured Stiris kept on top of SDV, facilitating two interim data cuts in a 5-month period.
  • Response from client “A huge thank you for all your support and patience.  I sincerely appreciate everything you have done.  You have gone above and beyond what was expected.  No one could have done this better than you did.”