Catalyst Oncology is a specialty oncology CRO devoting time, energy, and capital to supporting biotechs in bringing next-generation therapies to cancer patients. Oncology clinical research, particularly early-phase development, is complex, demanding, and continually evolving. Bringing effective therapies to proof-of-concept as fast as possible is our focus because every second counts for patients with cancer and their families.
Operationalizing early-phase oncology trials
Catalyst Oncology provides full-service support for Phase I through III development. With greater than 70% of our active portfolio in Phase I/II and first-in-human (FIH) clinical trials, we have especially deep expertise in managing early-phase oncology research. Our experts understand the complexities of Project Optimus trial designs, how to implement cohort management on a global scale, and how to be nimble and flexible with amendments and data review to reach required milestones rapidly. Our early-phase oncology site network connects us to Phase I specialty sites and principal investigators (PIs) to increase success in early-phase trials.
Challenges in Early-phase Oncology Trials
- Earlier dose optimization requirements
- Coordination of global cohort management, dose escalation, and expansion
- Increasingly complex study designs
- Access to more diverse patient populations
- Large global footprint required
- Greater upfront financial investment required
Catalyst Oncology’s Early-phase Expertise
- Collaborative, scientific, multidisciplinary teams
- Flexible, agile approach for small biotechs
- Early-phase site network with 20+ sites across US, UK, Spain, and Australia
- Global start-up and regulatory expertise
- Fluency with Project Optimus
- Drug development consulting
Active next-generation oncology experience
Working both locally and globally across Phases I through III in a range of solid tumor and hematologic indications, we understand the nuances of complex study designs, novel endpoints, and cutting-edge technologies.
