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 […]

Exceeds Sponsor Milestones after a Project Rescue

Background Stiris Research was brought in to rescue a North American CRPC Phase II clinical trial after a large global CRO was unable to meet recruitment and site start up timelines. Stiris was given a fixed deadline that all 30 sites needed to be initiated and 30 subjects enrolled by December 30. The rescue study […]

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 […]

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 […]