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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Therapy Area
Cardiovascular Devices
Navigating high-stakes regulatory pathways for life-critical devices
Therapy Area
Cardiovascular Devices
Navigating high-stakes regulatory pathways for life-critical devices
Therapy Area
Cardiovascular Devices
Navigating high-stakes regulatory pathways for life-critical devices
Overview
BSC supports cardiovascular device development from early feasibility through pivotal trials and post-market studies. Our cardiovascular portfolio includes structural heart devices, coronary interventions, heart failure management systems, and vascular access technologies.
Specialized Capabilities
Time-to-event analyses for MACE endpoints
Adjudication committee integration and CEC oversight
Bayesian hierarchical models for device performance across patient subgroups
Non-inferiority margin justification for cardiovascular devices
Sequential monitoring with alpha-spending functions for cardiovascular outcomes trials
Regulatory Experience
We have deep experience with CDRH cardiovascular device expectations, including appropriate historical controls, blinded endpoint assessment, and handling of competing risks. Our team understands the nuances of different cardiovascular indications—from coronary artery disease to structural heart disease to heart failure.
Representative Studies
Transcatheter heart valve systems (TAVR, TMVR)
Coronary stents and drug-eluting devices
Cardiac ablation systems
Heart failure monitoring and management devices
Peripheral vascular intervention devices
Design
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.
Analyze
Advance
Design
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.
Analyze
Advance
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®
Partner with us
Partner with us
Partner with us
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®