Cross-Cutting Therapeutic Capabilities
BSC leverages sophisticated approaches like propensity score analysis to address real-world evidence challenges, minimize bias, and build more persuasive regulatory narratives. Our nearly 40 years of FDA experience translates across all device categories, delivering regulatory success from early feasibility through post-market surveillance.
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.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"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
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company
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