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 the most high stakes situations.
800+
projects
Design, Analyze, Advance®
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On a Mission to help sponsors
We partner with Sponsors to design robust trials, deliver submission-ready analyses, and advance programs through FDA and regulatory review with clarity and confidence.
We Solve Problems.
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Core concentration
Biostatistical Consulting
Core service
Approval - Grade Results
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 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.
BSC® Solutions
Whatever stage you're in, we've been there.
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.
Demonstrated results
Experience that Regulators trust
Built on decades of practice
BSC® brings decades of FDA-facing experience to every engagement. Our statisticians have represented sponsors in hundreds of FDA meetings, contributed to landmark PMA trials, and built long-standing relationships across regulatory divisions. This depth of experience translates into clearer regulatory strategy, stronger submissions, and greater confidence at every stage of review.
BSC® statisticians have represented clients in hundreds of FDA meetings.
Decades-long relationships with CROs, regulatory advisors, and Sponsor partners.
Unparalleled track record in PMA trial design and analysis, particularly in orthopedics.
BSC® Founder Greg Maislin participated in 3 most recent FDA orthopedic panels and authored hundreds of peer-reviewed publications.
Best-in-class biostatistical team specializing exclusively in human clinical trials.
Trusted and respected by the FDA across multiple review divisions.
On a Mission to help sponsors
We partner with Sponsors to design robust trials, deliver submission-ready analyses, and advance programs through FDA and regulatory review with clarity and confidence.
Differentiator
What Sets Us Apart
Biomedical Statistical Consulting® (BSC®) specializes in regulatory biostatistics for medical device and pharmaceutical programs. We design smarter trials, deliver submission-grade analyses, and guide sponsors through complex FDA interactions with clarity and confidence.
With decades of experience across 510k, PMA, IDE, and pivotal studies, our work is built to withstand regulatory scrutiny and accelerate decision-making when it matters most.
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HEAD OFFICE
500 Terry Francine St,
San Francisco, CA 94158
123-456-7890
info@mysite.com
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