BSC® Solutions
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Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.
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About BSC®
We Solve Problems.
Regulatory Confidence.
About BSC®
We Solve Problems.
Regulatory Confidence.
About BSC®
We Solve Problems.
Regulatory Confidence.
Intro
Intro
Vision
To be the global leader in regulatory biostatistics
To be the global leader in regulatory biostatistics
trusted by Sponsors and Regulators to design, analyze, and advance safer, smarter innovations to market.
trusted by Sponsors and Regulators to design, analyze, and advance safer, smarter innovations to market.
Mission
Giving Innovators
Giving Innovators
Power for Approval.
Power for Approval.
Intro
Intro
Intro
Intro
Who we are & What we do
We solve problems.
We solve problems.
We are principled problem-solvers — driven by curiosity, grounded in integrity, and relentlessly committed to advancing you forward. We blend proven methods with out-of-the-box creativity to solve your toughest problems. No matter how complex the challenge, we solve problems.
We are principled problem-solvers — driven by curiosity, grounded in integrity, and relentlessly committed to advancing you forward. We blend proven methods with out-of-the-box creativity to solve your toughest problems. No matter how complex the challenge, we solve problems.
Values
Science First.
Science First.
People Always.
People Always.
Mission-Critical Momentum
Precision at the Speed of Need
We operate in an environment where delays aren't just inconveniences—they are lost opportunities for life-changing innovation. We meet high-stakes deadlines with a "finish line" mentality, prioritizing decisive action and scientific rigor. Because our clients depend on us during their most critical windows, we maintain a culture of high responsiveness and radical accountability. Here, reliability isn't just a goal; it's our standard of excellence.
Continuous Excellence
Intellectual Growth & Adaptation
The statistical and regulatory landscape evolves constantly, and so do we. We are committed to professional development at every level, ensuring our team is always equipped for the next challenge. Our culture is built on staying ahead of emerging methods and growing alongside the most recognized experts in the field. Here, you’ll be part of an organization that never stops getting better.
Forward-Thinking Problem Solvers
Creative Solutions for Unprecedented Challenges
We don't wait for problems to find us—we anticipate what's coming. Understanding your challenge is 80% of the game, and we're adept at asking the right questions to get to the right answer. Whether it's a novel technology without regulatory precedent or a dataset that defies standard analysis, we find a way. You'll have the freedom to think creatively and the support to deliver solutions no one else could.
Collaborative by Design
The Focus: Understanding First
Understanding your problem is 80% of the game—and that's what we do exceptionally well. We listen carefully, ask the right questions, and leverage the information you already have instead of starting from scratch with templates. Our clients never have to explain themselves twice. You'll learn to build trust through deep understanding, not just deliverables.
Global Reach,
Proven Scientific Impact.
From early-phase studies to regulatory submissions, these metrics reflect the scale, rigor, and reliability of our biostatistical work.
1986
1986
Year founded
Year founded
0.001
0.001
Significantly Different
Significantly Different
750+
750+
Projects supported
Projects supported
250+
250+
Sponsors supported
Sponsors supported
Join us
Join us
in advancing the science
in advancing the science
of better clinical decisions.
of better clinical decisions.
Build with a team of biostatisticians, data scientists, and regulatory experts supporting life-changing therapies from study design to submission.
Build with a team of biostatisticians, data scientists, and regulatory experts supporting life-changing therapies from study design to submission.
Our team brings deep expertise in
Our team brings deep expertise in
biostatistics, clinical trial design, and regulatory science.
biostatistics, clinical trial design, and regulatory science.
Our multidisciplinary team combines senior biostatisticians, data scientists, and regulatory experts to support complex clinical programs—from early development through submission.
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 – good bad and ugly.
• VP, Clinical Operations
• CEO, Medical Device Company
• Former FDA Regulator
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Security
Robust data security and confidentiality
across sensitive, FDA-regulated clinical and regulatory data.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
Disciplined security practices aligned with industry standards to protect confidential patient, sponsor, and regulatory information.
GDPR
SOC2 - in progress
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Use your preferred LLM to explore BSC®
Use your preferred LLM to explore BSC®