Rescue Case Study: Post Data Lock Monitoring

Background

A North American Biotech company had completed a Phase III study in Prostate Cancer with a large US CRO. The study was complete and the database locked. After reviewing the data, the Sponsor realized that many required site monitoring activities, including formal Close Out Visits had not occurred.

Challenge: To rapidly perform additional monitoring and COVs at 30 sites

  •  The Sponsor was concerned their pivotal trial data would not stand up to FDA scrutiny.

Solution:  A Robust Monitoring Action Plan to Address Insufficiencies

  • Stiris reviewed all of the original CRO’s existing monitoring reports to understand what had been completed and identify potential issues and areas of focus. An action plan was developed based on this review.
  • A coordinated team of experienced CRAs were assembled to monitor the sites.

Results:

  • Stiris CRAs completed previously missed monitoring activities, collected outstanding regulatory documents from sites, ensured the site files were complete and up-to-date and coordinated with Data Management to resolve new DCFs raised as result of additional monitoring.
  • Stiris completed this process within 5 weeks – from initial Sponsor contact to completion of the final COV.
  • The database was re-locked and the Sponsor avoided an audit.