BSC's Impact
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.
Our sponsors are funded by
Services
We partner with Sponsors to design robust trials, deliver submission-ready analyses, and advance programs through FDA and regulatory review with clarity and confidence.
Demonstrated results
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.
Differentiator
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.
Why BSC®
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Respiratory & Sleep Medicine
100's of Published papers demonstrating expertise in sleep and respiratory device trials
Cardiovascular Devices
Navigating high-stakes regulatory pathways for life-critical devices
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
Quality Through Listening
“They listen the first time. I’ve NEVER had to go back and re-spell out what I needed.”
”They work to understand the problem and leverage the information that is already there.”
• Former FDA Regulator
Why We Work With BSC
“GET STUFF DONE”
“They aren’t afraid to tackle difficult scenarios in compressed timelines.”
“When you have to do something no one else has done before.”
• CEO, Medical Device Company
