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
Diagnostics & Laboratory Medicine
Strategic partner for diagnostic device market entry
Overview
BSC® supports the 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 Studies
Molecular 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 — 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®