Catalyst Flex on Rapid CRA Deployment

A mid-size biotechnology company approached Catalyst Flex with a request to rescue site monitoring activities on two Phase III obsessive-compulsive disorder (OCD) registrational plus one long-term follow-up (LTFU) study.

This request included a total of 95 clinical sites across the U.S. and Canada with an enrollment target of 700 subjects per study. All 1,400 subjects were rolling into the LTFU program. The client required a rapid transition from the clinical research organization and a target to deploy clinical research associates (CRAs) to these sites within weeks of the contract execution.

Catalyst Flex delivered a study team structure to support of the client’s needs, which included:

• Project Director to provide program-level guidance and oversight
• 3 clinical trial leads, with 1 lead assigned to each study supporting CRAs and monitoring activities
• 28 CRAs to support monitoring activities across 95 clinical sites
• 3 in-house CRAs, with 1 assigned to each study to support centralized activities
• 3 additional CRAs to support eTMF filing and other support tasks

Catalyst Flex delivered a project team in record time using the following steps:

• Deployed a resourcing manager who reviewed the extensive Catalyst Flex database to identify clinical
  research professionals for each needed role
• Confirmed candidates, completed screenings and selections, and onboarding activities within two weeks
• Completed contracting, offer letters, IT and operational systems access set up
• Provided custom, off-cycle onboarding support for the study team to ensure rapid deployment to the sites
• CRAs were in the field by the start of Week 3