EARLY-PHASE ONCOLOGY RESEARCH

Early-phase Oncology Clinical Research for Biotech

Catalyst Oncology works exclusively with innovative biotechs on a range of early–phase study designs and next–gen therapies.

Catalyst Oncology supports early-phase research

Catalyst Oncology supports first-in-human (FIH), Phase I, combined Phase I/II, and Phase II studies. Our experts understand the operational complexities of coordinating multinational cohort management, dose escalation and expansion, and the amendments necessary to reach required milestones. Our early–phase oncology site network connects us to patients and professionals to succeed in early–phase trials.

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Why choose Catalyst Oncology for early-phase oncology clinical research studies?

At Catalyst Oncology, we can pioneer oncology advancements from the start. Here’s why you should choose us for your early–phase research.

Catalyst experience

Catalyst Oncology has served the biotech space for oncology clinical research since 2005, supporting over 150 studies. We draw on our robust and active pipeline for best practices and lessons learned.

Scientific excellence

Our multidisciplinary teams of experts translate scientific discoveries into potential therapies, driving advancements in oncology. We collaborate closely with sponsors, sites, investigators, and researchers to help develop innovative cancer therapies.

Early-phase site network model

We take a unique approach to site networks by forging dedicated, quality relationships with a small number of carefully selected sites in key countries renowned for their early–phase expertise. Our collaborative model empowers sites to deliver high-quality data, exceptional patient care while eliminating unnecessary, redundant processes and timeline delays.

Global start-up and regulatory expertise

Catalyst Oncology has a strong command of country-specific regulations and timelines for multinational or multi–regional trials. In addition to cultural differences, our global study teams are familiar with local regulatory, data privacy, and ethical requirements, and how these impact study start-up, site selection, cohort management, and trial logistics.

Flexible approach

We understand that change is inevitable in oncology clinical development. We pivot as your development plans evolve, such as when protocols amend or when Breakthrough Therapy designations move a product from Phase I/II to registration.

Drug development consulting

Catalyst Oncology Consulting provides clinical development planning, protocol writing, and regulatory consulting. Our oncology drug development team share with you study design, timeline modeling, and ballpark costing.

Knowledge of Project Optimus

With the goal of determining dose optimization sooner, the Food and Drug Administration’s (FDA) Project Optimus initiative has reshaped early–phase oncology research. Catalyst Oncology understands the impact Project Optimus has had, including more complex study designs, expanding sample sizes, and a larger global footprint.

My Catalyst team is an extension of my internal team. The team is very transparent and communicative. They are aware of the trial timelines and each department helps to keep the study on track.

The project team anticipates and provides solution-based responses to the current challenges on a given study, which is the essential need for any Sponsor as each protocol evolves and changes based on the clinical data collected.

Discover the Catalyst Oncology Difference

Explore our comprehensive early–phase research capabilities and learn how Catalyst Oncology drives forward your cancer research.

Start Your Early-phase Oncology Trial with Us