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, Hundreds of approved clients and projects.
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
Congratulations to BSC®’s David Maislin, Alex Breno, and our friends at 3Spine on their recent publication!
The article lays out the protocol for the pivotal IDE trial behind 3Spine's MOTUS® lumbar Total Joint Replacement, the first device built to restore both disc and facet joint function without sacrificing motion.
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
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.