Oncology Consulting

Consulting Services to Navigate Oncology Development

Catalyst Oncology Consulting helps you navigate the complexity of oncology drug development, tailoring a strategy unique to your program’s needs. We develop and deliver optimized drug development plans to enable clients to deliver their best assets to investors and patients.

Learn about Catalyst Oncology Consulting

Customized services across the entire development continuum

Catalyst Oncology Consulting supports clients across all phases of oncology development from lead optimization through new drug application (NDA) or biologics license application (BLA). Our consultancy services are designed to be delivered as a standalone service or seamlessly paired with a full-service oncology clinical trial offering.

Oncology services and experts to consult on complex studies

Catalyst Oncology Consulting provides services to support the full development of your asset from preclinical, drug discovery services (including translational and clinical science to chemistry, manufacturing and controls, and toxicology) to clinical development planning, filing, global regulatory strategy, and agency submission.

Preclinical

Development strategy and planning
Portfolio assessment
Vendor ID and oversight
Toxicology
Pharmacokinetics (PK) / Pharmacodynamics (PD)
Chemistry, manufacturing, and controls (CMC)

Clinical

Clinical development plan
Protocol development
Phase III study review
Meta analysis
Meeting plan, preparation, attendance, and follow-up
Special designations
CMC
Quality management system (QMS)

Regulatory

Global agency interaction
Preparation and submissions
Compliance
Labeling review
Pre-IND / INTERACT meetings
IND submission and maintenance

Our experts serve as an extension of your study team

We are your partners in product development, serving as an extension of your study team. Averaging 20+ years of experience, our network of specialized experts listen to your needs, develop flexible, custom solutions, and integrate seamlessly into your team—offering a true collaboration and understanding of your project.

Biomarker and translational scientists

Biostatisticians and PK/PD experts

Clinical operations and clinical oncologists

CMC

Development strategy and regulatory experts

Feasibility and market intelligence

Medical writing

Toxicology

Catalyst clearly demonstrated they have the expertise and connections to evaluate this scenario thoroughly. They were very easy to work with and the quality of the output we received, together with its speed, was impressive.

Catalyst Oncology has been instrumental in advancing our research efforts. Their expertise and dedication have been invaluable.

Four people facing each other in a sunlit room at a conference table

Discover our drug development strategy workshops

Catalyst offers the opportunity to assemble industry-leading experts in a dedicated full– or half–day workshop to assess the progress of your asset’s development. Following a thorough analysis and discussion with your team, we will provide insights and suggestions around optimizing the developmental activities and pathway for your program.

Learn More about Scheduling a Drug Development Strategy Workshop

A research organization to consult and support your oncology trials

Deep consulting expertise and understanding increases efficiencies to succeed throughout clinical trial milestones.

Expert Consulting Services for Oncology

Reach out to Catalyst Oncology Consulting to discover how we can support your oncology program’s drug development needs.