VOICES

Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.

Therapy Area

Oncology

Expertise in complex benefit-risk determinations

Therapy Area

Oncology

Expertise in complex benefit-risk determinations

Therapy Area

Oncology

Expertise in complex benefit-risk determinations

Overview
BSC supports oncology clinical trials for both therapeutics and devices, including surgical oncology devices, radiation therapy systems, diagnostic technologies, and supportive care devices. Our experience spans solid tumors and hematologic malignancies.​
Specialized Capabilities

  • Overall survival and progression-free survival endpoint design

  • Adaptive designs for dose-finding and seamless Phase II/III trials

  • Response evaluation criteria (RECIST, iRECIST) implementation

  • Competing risks analysis for oncology outcomes

  • Propensity score methods for real-world evidence studies​
    Regulatory Experience
    We understand oncology division expectations for time-to-event endpoints, interim analysis strategies, and appropriate alpha-spending approaches. Our team has experience with accelerated approval pathways, breakthrough therapy designations, and surrogate endpoint justification.​
    Representative Studies

  • Surgical oncology devices (ablation, resection)

  • Radiation therapy planning and delivery systems

  • Cancer diagnostic and monitoring devices

  • Supportive care technologies (pain management, symptom control)

  • Minimal residual disease detection systems

Design

We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.

Analyze

Advance

Design

We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.

Analyze

Advance

Testimonials

See what our sponsors say about BSC

On Experience

Battle ground tested. There is nothing that David and team haven't seen over the years – good bad and ugly.

• VP, Clinical Operations

• CEO, Medical Device Company

• Former FDA Regulator

Questions answered

Any other question?

Let's help you find a path

to get your idea into the market

  • About & Services

    Working With BSC

    Trial Design & Methodology

    Regulatory & FDA

    Analysis & Programming

    Cost & Contracting

    Expertise & Qualifications

    Practical Considerations

    Common Concerns

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Questions answered

Any other question?

Let's help you find a path

to get your idea into the market

  • About & Services

    Working With BSC

    Trial Design & Methodology

    Regulatory & FDA

    Analysis & Programming

    Cost & Contracting

    Expertise & Qualifications

    Practical Considerations

    Common Concerns

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Questions answered

Any other question?

Let's help you find a path

to get your idea into the market

  • About & Services

    Working With BSC

    Trial Design & Methodology

    Regulatory & FDA

    Analysis & Programming

    Cost & Contracting

    Expertise & Qualifications

    Practical Considerations

    Common Concerns

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Questions answered

Any other question?

Let's help you find a path

to get your idea into the market

  • About & Services

    Working With BSC

    Trial Design & Methodology

    Regulatory & FDA

    Analysis & Programming

    Cost & Contracting

    Expertise & Qualifications

    Practical Considerations

    Common Concerns

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Biomedical Statistical Consulting®
Biomedical Statistical Consulting®
Biomedical Statistical Consulting®
Biomedical Statistical Consulting®

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.