Since 2020, Catalyst Oncology has supported an emerging biotech’s oncology program. Focused on developing the first new bladder cancer treatment in over two decades, the sponsor turned to Catalyst for functional services and strategic guidance across a portfolio of studies, including a pivotal Phase III trial.
Catalyst demonstrated our customized, flexible model and proven ability to adapt to shifting priorities, evolving clinical demands, and complex organizational dynamics—all amid the challenges of a global pandemic.
The challenge
The partnership began with Catalyst supporting two key bladder cancer studies—a Phase I/II combination therapy trial and a Phase III monotherapy trial—during a period of rapid growth and external disruption. The onset of the COVID-19 pandemic introduced immediate challenges, particularly around patient enrollment. Simultaneously, the sponsor’s evolving internal priorities led to shifts in study scope, resourcing models, and vendor relationships.
As the biotech scaled, several internal systems, including EDC, CTMS, and eTMF, were still being implemented or optimized. Catalyst stepped in to bridge gaps, developing interim solutions and offering best-practice guidance to ensure continuity. These dynamics added complexity to site activation, enrollment, and overall operational execution.
The solution
Catalyst led the sponsor’s oncology program with a customized, full-service approach tailored to evolving needs. The project team delivered global project management across three CROs, ensuring alignment and oversight across a complex, multi-partner landscape. Functional services, including site management, biostatistics, clinical monitoring, data management, safety, and eTMF management, were flexed as needed to meet changing demands.
Catalyst also led site activation for a new study arm, onboarding 15 additional US sites with consistent, trusted staffing. The team provided consultative support on eligibility criteria, TMF indexing, and system implementation—often stepping in to guide and educate internal sponsor teams. When system issues disrupted serious adverse event (SAE) reporting, Catalyst quickly adapted workflows to maintain data quality. The sponsor was impressed with Catalyst’s key functions, citing the team’s continuity, responsiveness, and ability to deliver under pressure.
The outcome
Catalyst remained a steady and trusted partner. Catalyst Oncology’s strategic leadership and operational excellence helped the sponsor achieve Fast Track Designation and complete a successful IPO. The sponsor has named Catalyst its preferred safety provider and awarded additional work, including an Expanded Access Program and safety oversight for its Phase III study.
What began as a targeted engagement has evolved into a long-term partnership built on trust, flexibility, and shared success. Catalyst’s demonstrated ability to engage with the sponsor across technological, operational, and strategic domains has established us as the partner of choice on the biotech’s journey toward regulatory submission and commercialization.
