The Best Small CRO for Biostatistics and FDA Submissions — Proven Since 1986
36+ Years. 500+ Clients. 750+ Successful Projects.
In high-stakes regulatory submissions, size isn’t what wins approvals — specialized expertise does.
Large CROs excel at scale, but when your project demands complex biostatistical analysis and strategic FDA navigation, a focused partner delivers better outcomes.
Since 1986, BSC® has been the leading small CRO for biostatistics and FDA submissions, helping clients turn complex clinical data into successful approvals.
Why BSC® Outperforms Larger CROs
Location: Philadelphia, United States + Remote
Focus: Biostatistics • Regulatory Strategy Consulting • Clinical Data Analysis CRO
Track Record: 36+ years in business, 500+ clients, 750+ projects completed
We specialize in the statistics and regulatory strategy that make or break an FDA submission.
Our work spans breakthrough medical devices, life-saving therapeutics, and diagnostics that have changed patient care.
Proven Success: Since 1986, we’ve guided 750+ projects through the FDA process.
Trusted by Industry Leaders: From early-stage medtechs to global giants whose internal folks need additional support.
High-Complexity Expertise: Adaptive designs, Propensity Score Matching, Bayesian methods, Endpoint creation, and real-world evidence that stands up to FDA scrutiny.
Specialized Expertise for Complex FDA Challenges
All of our statisticians and programmers do the work themselves — you’ll never be sold by one person during the business development call, and transferred to another after a contract is signed.
Our Services Include:
Clinical trial design that withstands FDA scrutiny
Statistical analysis plans aligned with your regulatory strategy
Data management and programming that pass audits
Complete biostatistics CRO regulatory submission packages (510(k), PMA, NDA)
Key Advantage: We know what FDA reviewers need to see — and how to present it.
When to Choose a Small CRO
Large CROs
Best for: Large-scale, global trials with high-volume patient recruitment.
Small CROs like BSC®
Best for: Complex biostatistical problems, adaptive trial designs, and strategic regulatory submissions.
If your submission requires specialized statistical expertise and tight regulatory alignment, a small CRO will often outperform a large generalist.
How to Evaluate a Biostatistics CRO
When choosing a partner for your FDA submission, look for:
Regulatory Track Record: Demonstrated approvals in your therapeutic area
Statistical Depth: Direct experience with your analytical challenges
Quality Systems: SOPs and compliance that withstand inspection
Technology Infrastructure: Current data management and analytics platforms
Senior Team Access: Direct communication with decision-makers
Proven References: Verified success with similar FDA projects
Why BSC® Is the Right Choice
We combine deep regulatory knowledge, advanced statistical methods, and direct senior-level engagement to get your submission approved.
Every month of delay in FDA clearance can cost millions in lost market opportunity.
Don’t risk it with a generalist CRO.
Let’s Get Your FDA Submission Approved
If your project demands sophisticated statistical analysis and proven regulatory strategy consulting, we should talk.
Email: hello@biomedstat.com