Phase III Rare Disease Study

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.

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.

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.