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.
BSC®
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.
It all begins with a hypothesis. Maybe you need to design a clinical trial that will change patient outcomes. Maybe you want to transform complex data into actionable insights that drive regulatory approval. Or maybe you have groundbreaking research that requires rigorous statistical validation to reach the world. Whatever your biomedical challenge, the way you design your study, analyze your data, and advance your findings can make all the difference between scientific discovery and regulatory success.
Design.
We craft robust study protocols and statistical frameworks that ensure your research meets regulatory standards from day one.
Analyze.
We transform complex biomedical data into clear, actionable insights that drive confident decision-making and regulatory submissions.
Advance.
We accelerate your path to market by delivering the statistical evidence and documentation needed for successful regulatory approval.
Design. Analyze. Advance.™
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