Core concentration
Biostatistical Consulting
Core service
Approval - Grade Results
Design
Specializing in designing clinical trials to secure FDA approval of a drug or medical device.
Analyze
Delivering precision, auditability, and regulatory confidence.
Advance
Analyzing ongoing clinical trial submissions and/or after their completion.
Decades of leadership.
Proven regulatory outcomes.
Our work focuses on defensible analyses, clear communication, and outcomes that stand up to regulatory scrutiny.
BSC® supports sponsors across the full clinical development lifecycle with rigorous, regulator-facing biostatistics.
BSC® Credibility
Proven Regulatory Expertise in
Designing, Analyzing, Advancing Clinical Trials
BSC® supports sponsors across the full clinical development lifecycle with rigorous, regulator-facing biostatistics.
We partner with Sponsors to design robust trials, deliver submission-ready analyses, and advance programs through FDA and regulatory review with clarity and confidence.
36+
years
FDA facing Leadership.
500+
clients
Reputation earned through success in high stakes situations.
800+
projects
Design. Analyze. Advance.®
We Solve Problems.
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.
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Biomedical Statistical Consulting® (BSC®) is a specialized biostatistics regulatory consulting firm supporting life-science companies from early study design through FDA approval.
We work with teams developing medical devices, diagnostics, and therapeutics in highly regulated environments, providing statistical rigor and regulatory clarity where scrutiny is high and decisions matter.
BSC® combines deep biostatistical expertise with hands-on FDA experience. Engagements are led by in-house experts who work directly with clients to reduce risk, strengthen submissions, and support successful regulatory outcomes.
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
BSC® Partners
Trusted by Investors Globally.
