Benefits Of Working With Catalyst Oncology Versus A Large Generalist CRO

By Keya Watkins

Oncology drug development has become one of the most complex and resource-intensive areas in clinical research, demanding expertise that large generalist CROs were not built to provide. The rise of precision medicine, immuno-oncology, and regulatory shifts, such as the FDA’s Project Optimus, has introduced more adaptive early-phase trial designs, global patient recruitment challenges, and intricate IMP logistics. These demands highlight the growing gap between traditional CRO operating models and the specialized needs of oncology sponsors.

Specialty oncology CROs, such as Catalyst Oncology, bridge this gap by embedding deep oncology expertise across every function—from CRAs and data managers to statisticians and safety specialists. Unlike generalist CROs that often repurpose teams across therapeutic areas, an oncology-only CRO provides study teams fluent in cancer trial complexities, from interpreting partial responses to managing adverse events of special interest. By combining a global footprint with oncology-specific technologies and site relationships, specialty CROs deliver the adaptability, scientific insight, and operational rigor needed to accelerate oncology programs from first-in-human through registrational trials—making them the ideal partner for biotechs advancing the next generation of cancer therapies.