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.
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.
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Therapy Areas
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 — Bayesian design, adaptive clinical trial design, and Propensity Score Matching — to reduce costs, overcome limited data access, and minimize 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 – the good, bad, and ugly.”
• Vice President, Clinical Operations
• Former FDA Regulator
• CEO, Medical Device Company
Featured Resources
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from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
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®