Rescue Case Study: Flexible Resourcing to Meet Database Lock

Background

A North American Pharma company was running a Phase IV Diabetes study at 134 sites in Canada and the US.  Seven weeks before database lock, the incumbent CRO indicated they did not have the resources to complete monitoring and Close Out Visits for 49 of the 134 sites. The date for database lock was in danger of being delayed by two to three months.

Challenge: To Perform Monitoring and Close Out Activities for 49 sites

Solution:  Rapid and Responsive Monitoring Team Deployment

  • Stiris applied a team of 7 experienced CRAs to perform Close Out Visits for 49 sites.
  • Following Stiris’ engagement, the original CRO informed the Sponsor that they could no longer meet their site monitoring obligations for an additional 50 sites, further threatening database lock.
  • Within 1 week Stiris expanded the team to manage monitoring and closeout activities for the additional 50 sites.

Results:

  • Stiris assisted the Sponsor with site relationship repair and development.
  • Within 6 weeks, Stiris performed final monitoring visits, resolved DCFs and performed final Close Out Visits and related activities at 99 sites.
  • The Sponsor achieve their original target date for database lock.