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.