Design.
Analyze.
Advance.™
Empowering Clinical Trials Through Creative Collaboration
The fusion of human creativity and technological expertise leads to groundbreaking solutions in clinical trials. Our team thrives on challenges, approaching each project with a fresh perspective and an unwavering commitment to innovation. When the path isn't clear, we leverage our decades of experience to chart a new one — because no challenge is too great when human ingenuity leads the way.
About us
Biomedical Statistical Consulting® (BSC®) is a best-in-class contract research organization specializing in biostatistical support services for regulatory, clinical trials, and biomedical studies.
Since 1986, BSC® has supported hundreds of successful studies and agency interactions of medical devices, from pilot studies to pivotal and post-approval studies, early and later pharmaceutical trials, and leading-edge investigator-initiated medical research studies at major academic centers throughout the world.
What we do
Design
From concept to strategy, we design regulatory-ready trials that meet FDA expectations and accelerate development timelines. Our expertise ensures every protocol, endpoint, and analysis plan is rooted in statistical rigor and clinical relevance.
Analyze
We deliver trusted, submission-grade analyses using validated methods and robust statistical techniques. Every dataset and model is optimized to maximize insight, demonstrate efficacy, and support claims in alignment with FDA and global regulatory standards.
Advance
We translate data into compelling evidence. Our submission packages are tailored for regulatory reviewers, combining clear narratives, powerful visuals, and transparent justifications to support approval decisions.
What sets us apart
Unparalleled track record in PMA trial design and analysis, particularly in orthopedics
Decades-long relationships with clinical research organizations, regulatory advisors, and industry sponsors
Trusted and respected by the FDA
BSC® Founder Greg Maislin has participated in the three most recent FDA orthopedic panels and published hundreds of medical research articles.
BSC® statisticians have represented clients in person and on the phone at hundreds of meetings with the FDA
Best-in-class biostatistical team specializes in human clinical trials
