Biotech hires Catalyst Flex to rescue and reverse trial declines
A small biotech needed functional support for a Phase III rare disease study. Although a contract existed between the biotech and a clinical research organization (CRO), the study timelines and budget had slipped. The biotech hired Catalyst Flex to reverse that trend and ultimately saved ~$1 million.
The challenge
A small biotech with limited internal capacity outsourced to a clinical research organization a Phase III clinical program for patients with necrotizing soft tissue infections, a rare, life-threatening infection for which no therapy currently exists. The study was to be conducted with 60 U.S. sites with the objective of enrolling 290 patients.
After nearly 16 months, patient enrollment was still a major challenge and the CRO was not proactive in addressing the issues and providing solutions. Adding to the difficulties, the study was over budget and CRO staff turnover on the project was extremely high. The relationship had significantly deteriorated between the CRO and the Sponsor. The Sponsor retrieved control of its study.
The Sponsor’s executive management decided to bring the study in-house and hired targeted operations professionals to accommodate the new workload. Despite the hiring, the Sponsor still had infrastructure and resourcing gaps, including lack of access to clinical standard operating procedures (SOPs) and a blinded and unblinded field monitoring team, before beginning the study transition from the CRO.
The solution
Catalyst Flex became part of the solution for the Sponsor’s necrotizing soft tissue infections Phase III study.
Catalyst Flex listened and provided 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 and hospital-based study experience. The team was hand selected by Catalyst and the Sponsor to ensure geographic, therapeutic, and cultural alignment.
The outcome
The Catalyst Flex monitoring team became an extension of the Sponsor’s team, serving as ambassadors to their assigned study centers.
The Sponsor’s model of internal management and study oversight alongside the Catalyst Flex blinded and unblinded monitoring support, allowed the Sponsor to regain control of the research. Although patient enrollment continued to be a study challenge, significant headway was made over the next 18 months by applying resources where needed, including site support and enrollment strategies. In addition, the Sponsor acknowledged that Catalyst Flex pricing saved them ~$1 million in study execution compared with the CRO’s projections, while providing high-quality service delivery. Since then, Catalyst was awarded a second study providing unblinded and blinded monitoring for a Phase II study in acute kidney injury in the U.S. and Europe.
