We Solve Problems.
Giving innovators power for approval.
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.
Who We Are + What We Do
At BSC®, we solve problems.
Driven by curiosity, grounded in integrity, and relentlessly committed to advancing you forward.
We blend proven methods with out-of-the-box creativity to solve your toughest problems. No matter how complex the challenge, we solve problems.
40+ years
800+ projects
500+ sponsors
Approval Grade Experience, Quantified.
Our Journey in Numbers
Proven Scientific Impact
800+ projects
Advancing New Frontiers
40+ years
Across The Globe
500+ sponsors
Design. Analyze. Advance.®
Vision
To be the global leader in regulatory biostatistics,
trusted by Sponsors and Regulators to design, analyze, and advance safer, smarter innovations to market.
Mission
Giving Innovators
Power for Approval.
Values
Science First.
People Always.
Mission Critical Momentum
Precision at the Speed of Need
Continuous Excellence
Intellectual Growth and Adaptation
Forward Thinking Problem Solvers
Creative Solutions for Unprecedented Challenges
Collaborative by Design
The Focus: Understanding First
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
