Catalyst Flex Assists Biotech for Research Program
A small biotech with limited internal capacity outsourced a Phase III clinical program in patients with necrotizing soft tissue infections, a rare, life-threatening infection for which no therapy currently exists, to a clinical research organization (CRO). The study was to be conducted with 60 U.S. sites with the objective of enrolling 290 patients.
Situation
The sponsor’s executive management made the decision to bring the study inhouse, hiring targeted operations professionals to accommodate the new workload. Despite the hiring they still had infrastructure and resourcing gaps including no access to clinical standard operating procedures (SOPs) or a blinded and unblinded field monitoring team, before they could begin to transition the study from the existing CRO.
Solution
The sponsor engaged Catalyst Flex to provide a blinded and unblinded monitoring team that reported into the sponsor’s clinical trial manager (CTM) using Catalyst’s SOPs. The team consisted of veteran clinical research associates (CRAs) with extensive critical care, hospital-based study experience. The staff was hand selected by Catalyst and the sponsor to ensure geographic, therapeutic, and cultural alignment.
Outcome
The monitoring team became an extension of the sponsor’s team, serving as ambassadors to their assigned study centers.
The sponsor is thrilled with the model of internal management and study oversight. The sponsor utilized Catalyst Flex for blinded and unblinded monitoring support, allowing the sponsor to retain control of the program.
Catalyst Flex has the experienced staff to address specific needs for your research.
