Oncology Biotech Consulting

PRO Measurement Strategy

Selecting measures that satisfy FDA expectations for disease-related symptoms, symptomatic AEs, and their impact.

Regulatory Considerations

Driving regulatory-ready measurement science across all development phases.

eCOA & Trial Design Complexity

Ensuring solutions meet complexities inherent in oncology protocols.

Early Phase & Dose Optimization

Building COA strategy into dose-finding to inform accurate tolerability characterization.

Proactive Patient Monitoring

Exploring how real-time ePRO can support early intervention for side-effect management.

Supply Chain for Oncology

Planning RTSM and supply strategies for platform, basket, umbrella, adaptive, and short-supply studies.

Biotech and pharma sponsors

across all oncology development phases (including CMOs and clinical leaders)

Clinical operations leaders

planning eCOA, RTSM, or eConsent vendor selection

Regulatory affairs teams

navigating FDA PRO guidance in oncology

Biostatisticians and PRO/COA scientists

designing endpoints and estimand strategy

Clinical data management leaders

supporting oncology trial design and analysis

CRO partners

managing oncology study design on behalf of sponsors

Submit Your Request

Fill in the form with your indication, trial phase, and what you'd like to cover. Takes two minutes.

We Review and Assign an Expert

Within one business day, we'll review your request and confirm your consultation details.

You Receive a Calendar Invite

Video or phone, your preference. Share your protocol outline, draft synopsis, or open questions about your trial.

A Real Conversation

Our oncology scientists focus on your specific program. You leave with a clearer picture of what good looks like for your trial.

Talk to our oncology science team before you lock your protocol.

Start the Conversation

What We Can Cover