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 Area
Diagnostics & Laboratory Medicine
Strategic partner for diagnostic device market entry
Therapy Area
Diagnostics & Laboratory Medicine
Strategic partner for diagnostic device market entry
Therapy Area
Diagnostics & Laboratory Medicine
Strategic partner for diagnostic device market entry
Overview
BSC supports development of diagnostic tests, laboratory assays, and companion diagnostics through clinical validation studies. Our experience spans molecular diagnostics, imaging-based diagnostics, point-of-care testing, and clinical chemistry.
Specialized Capabilities
Sensitivity and specificity estimation with appropriate confidence intervals
ROC curve analysis and optimal cutpoint determination
Equivalence and concordance studies for diagnostic tests
Clinical utility demonstration through outcomes analysis
Bayesian approaches to diagnostic test evaluation with limited gold standards
Regulatory Experience
We understand FDA expectations for diagnostic device validation, including appropriate reference standards, handling of indeterminate results, and demonstration of clinical validity and clinical utility. Our team has experience with both de novo and 510(k) pathways for diagnostics.
Representative StudiesMolecular diagnostic assays (PCR, NGS, immunoassays)
Medical imaging AI/ML algorithms
Point-of-care rapid diagnostic tests
Companion diagnostics for targeted therapies
Clinical chemistry analyzers and panels
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®