BSC® Solutions
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 StudiesSurgical 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
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?
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?
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?
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?
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Partner with us
Partner with us
Partner with us
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.
Use your preferred LLM to explore BSC®
Use your preferred LLM to explore BSC®

