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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Approval-Grade
Approval-Grade
Biostatistics
Biostatistics
Medical Device and Life Sciences
Medical Device and Life Sciences
We partner with life science teams to design, analyze, and defend clinical trials — delivering FDA-ready statistics and regulatory confidence.
We partner with life science teams to design, analyze, and defend clinical trials — delivering FDA-ready statistics and regulatory confidence.
BSC's Impact
Decades of statistical leadership.
Decades of statistical leadership.
Proven regulatory outcomes.
Proven regulatory outcomes.
Our work focuses on defensible analyses, clear communication, and outcomes that stand up to regulatory scrutiny.
BSC® supports sponsors across the full clinical development lifecycle with rigorous, regulator-facing biostatistics.
FDA-facing biostatistical leadership.
FDA-facing biostatistical leadership.
FDA-facing biostatistical leadership.
Reputation earned through success in the most high stakes situations.
Reputation earned through success in the most high stakes situations.
Reputation earned through success in the most high stakes situations.
Designed, Analyzed, Advanced.™
Designed, Analyzed, Advanced.™
Designed, Analyzed, Advanced.™
Our sponsors are funded by
Services
Designated to help sponsors
Designated to help sponsors
Design Clinical Trials.
Design Clinical Trials.
We partner with Sponsors to design robust trials, deliver submission-ready analyses, and advance programs through FDA review with clarity and confidence.
With decades of experience across PMA, IDE, and pivotal studies, our work is built to withstand regulatory scrutiny and accelerate decision-making when it matters most.
Design
Analyse
Advance
We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.
Design
Analyse
Advance
We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.
Approval-Grade
Results
Demonstrated results
Experience that Regulators trust
Experience that Regulators trust
Built on decades of practice
Built on decades of practice
BSC® brings decades of FDA-facing experience to every engagement. Our statisticians have represented sponsors in hundreds of FDA meetings, contributed to landmark PMA trials, and built long-standing relationships across regulatory divisions. This depth of experience translates into clearer regulatory strategy, stronger submissions, and greater confidence at every stage of review.
BSC® statisticians have represented clients in hundreds of FDA meetings.
Decades-long relationships with CROs, regulatory advisors, and Sponsor partners.
Unparalleled track record in PMA trial design and analysis, particularly in orthopedics.
BSC® Founder Greg Maislin participated in 3 most recent FDA orthopedic panels and authored hundreds of peer-reviewed publications.
Best-in-class biostatistical team specializing exclusively in human clinical trials.
Trusted and respected by the FDA across multiple review divisions.
BSC® statisticians have represented clients in hundreds of FDA meetings.
Best-in-class biostatistical team specializing exclusively in human clinical trials.
BSC® Founder Greg Maislin participated in 3 most recent FDA orthopedic panels and authored hundreds of peer-reviewed publications.
Unparalleled track record in PMA trial design and analysis, particularly in orthopedics.
Decades-long relationships with CROs, regulatory advisors, and Sponsor partners.
Trusted and respected by the FDA across multiple review divisions.
BSC® statisticians have represented clients in hundreds of FDA meetings.
Unparalleled track record in PMA trial design and analysis, particularly in orthopedics.
Best-in-class biostatistical team specializing exclusively in human clinical trials.
Decades-long relationships with CROs, regulatory advisors, and Sponsor partners.
BSC® Founder Greg Maislin participated in 3 most recent FDA orthopedic panels and authored hundreds of peer-reviewed publications.
Trusted and respected by the FDA across multiple review divisions.
Differentiator
What Sets Us Apart
What Sets Us Apart
Proven Regulatory Experience.
Proven Regulatory Experience.
Proven Regulatory Experience.
Biomedical Statistical Consulting® (BSC®) specializes in regulatory biostatistics for medical device and pharmaceutical programs. We design smarter trials, deliver submission-grade analyses, and guide sponsors through complex FDA interactions with clarity and confidence.
With decades of experience across 510k, PMA, IDE, and pivotal studies, our work is built to withstand regulatory scrutiny and accelerate decision-making when it matters most.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs — from early feasibility through submission and post-market requirements.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs — from early feasibility through submission and post-market requirements.
Senior experts, not junior teams
Every engagement is led by experienced biostatisticians and regulatory specialists — not handed off to junior staff.
Senior experts, not junior teams
Every engagement is led by experienced biostatisticians and regulatory specialists — not handed off to junior staff.
Flexible, fit-for-purpose solutions
No rigid packages. Scope exactly what you need — from focused analyses to full submission support.
Flexible, fit-for-purpose solutions
No rigid packages. Scope exactly what you need — from focused analyses to full submission support.
Proven FDA experience
Hands-on experience across FDA pathways, statistical reviews, and regulator interactions — reducing risk and rework.
Proven FDA experience
Hands-on experience across FDA pathways, statistical reviews, and regulator interactions — reducing risk and rework.
Why BSC®
How BSC® Compares
How BSC® Compares
to Traditional CROs and Consultants
to Traditional CROs and Consultants
BSC®
BSC®
BSC®
Traditional CRO
Traditional CRO
Traditional CRO
Academic Consultant
Academic Consultant
Academic Consultant
Single Consultant
Single Consultant
Single Consultant
Internal Team
Internal Team
Internal Team
Medical Device Specialization
Deep expertise in musculoskeletal, neurological, and diagnostic devices with specialized understanding and development of unique regulatory pathways.
Medical Device Specialization
Deep expertise in musculoskeletal, neurological, and diagnostic devices with specialized understanding and development of unique regulatory pathways.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Direct Senior Engagement with Team Support
Expert biostatisticians work directly on your projects, backed by full team infrastructure and capacity.
Direct Senior Engagement with Team Support
Expert biostatisticians work directly on your projects, backed by full team infrastructure and capacity.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
FDA Advisory Panel Experience
Successfully represented device sponsors in multiple FDA advisory panel reviews, with firsthand understanding of panel dynamics and concerns.
FDA Advisory Panel Experience
Successfully represented device sponsors in multiple FDA advisory panel reviews, with firsthand understanding of panel dynamics and concerns.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
40-Year FDA Track Record
Four decades of successful medical device regulatory submissions and FDA strategy, with institutional knowledge of evolving regulatory requirements.
40-Year FDA Track Record
Four decades of successful medical device regulatory submissions and FDA strategy, with institutional knowledge of evolving regulatory requirements.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Production-Ready Advanced Statistical Methods
Precision studies, method comparison, equivalence testing, Bayesian approaches, and complex study designs.
Production-Ready Advanced Statistical Methods
Precision studies, method comparison, equivalence testing, Bayesian approaches, and complex study designs.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Time-to-Submission Agility
No 'Large-CRO' bureaucracy. Direct communication lines mean analysis pivots happen in days, not weeks.
Time-to-Submission Agility
No 'Large-CRO' bureaucracy. Direct communication lines mean analysis pivots happen in days, not weeks.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Proprietary Statistical Software & Methods
Specialized methods for challenging regulatory scenarios: real-world evidence when RCTs aren't feasible, adaptive designs when enrollment is difficult, and propensity matching for post-market studies - all with FDA-validated code
Proprietary Statistical Software & Methods
Specialized methods for challenging regulatory scenarios: real-world evidence when RCTs aren't feasible, adaptive designs when enrollment is difficult, and propensity matching for post-market studies - all with FDA-validated code
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Logistics & Site Monitoring (Boots-on-the-ground)
Site coordination, monitoring, and recruitment.
Logistics & Site Monitoring (Boots-on-the-ground)
Site coordination, monitoring, and recruitment.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Program-Level Statistical Strategy
Continuity across multiple submissions and products with institutional knowledge of your development program.
Program-Level Statistical Strategy
Continuity across multiple submissions and products with institutional knowledge of your development program.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Regulatory Narrative & Submission Rescue
Expertise in salvaging flawed submissions, performing forensic re-analysis of "inherited" data, and crafting scientific justifications for FDA AI/Major Deficiency letters.
Regulatory Narrative & Submission Rescue
Expertise in salvaging flawed submissions, performing forensic re-analysis of "inherited" data, and crafting scientific justifications for FDA AI/Major Deficiency letters.
BSC
Traditional CRO
Academic Consultant
Single Consultant
Internal Team
Therapy Areas
Deep biostatistical expertise
Deep biostatistical expertise
across complex, FDA-regulated
clinical programs.
across complex, FDA-regulated
clinical programs.
Respiratory & Sleep Medicine
100's of Published papers demonstrating expertise in sleep and respiratory device trials
Cardiovascular Devices
Navigating high-stakes regulatory pathways for life-critical devices
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®