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.
Therapy Areas
Cross-Cutting Therapeutic Capabilities
Advanced statistical methods that strengthen regulatory submissions
Cross-Cutting Therapeutic Capabilities
Real-World Evidence
Propensity score matching and weighting across all therapeutic areas. Synthetic control arm methodology. Registry data analysis and integration. Post-market surveillance study design.
Rare Diseases
Small population trial design. Historical control and performance goal approaches. Bayesian methods for borrowing information. Adaptive designs for efficient evidence generation.
Digital Health
Software as a Medical Device (SaMD) validation. Algorithm performance assessment. Human factors integration into clinical endpoints. Mobile health monitoring and compliance analysis.
Combination Products
Device-drug combination statistical strategies.
Co-primary endpoint designs.
Integrated safety assessment across modalities.
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.
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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
Quality Through Listening
“They listen the first time. I’ve NEVER had to go back and re-spell out what I needed.”
”They work to understand the problem and leverage the information that is already there.”
• Former FDA Regulator
Why We Work With BSC
“GET STUFF DONE”
“They aren’t afraid to tackle difficult scenarios in compressed timelines.”
“When you have to do something no one else has done before.”
• CEO, Medical Device Company
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
Quality Through Listening
“They listen the first time. I’ve NEVER had to go back and re-spell out what I needed.”
”They work to understand the problem and leverage the information that is already there.”
• Former FDA Regulator
Why We Work With BSC
“GET STUFF DONE”
“They aren’t afraid to tackle difficult scenarios in compressed timelines.”
“When you have to do something no one else has done before.”
• CEO, Medical Device Company
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®
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®