BSC® Solutions
VOICES
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.
BSC® Solutions
VOICES
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.
Therapy Areas
Women's Health
Regulatory strategy for reproductive and maternal health innovations
Women’s Health
Overview
BSC provides specialized statistical support for women's health devices and therapeutics, including obstetric monitoring, gynecological surgical devices, contraceptive technologies, and pelvic health products. Our experience spans reproductive health across the lifespan.
Specialized Capabilities
Composite obstetric outcome endpoint design. Handling of clustered data in obstetric trials (multiple pregnancies per woman). Long-term follow-up strategies for contraceptive effectiveness studies. Quality of life assessments specific to women's health conditions. Risk-benefit assessment for maternal-fetal interventions.
Regulatory Experience
We understand unique considerations in women's health trials, including appropriate safety assessments, handling of pregnancy-related complications, and long-term durability evaluation for implantable devices. Our team has experience with contraceptive effectiveness calculations and pelvic floor disorder outcome measures.
Representative Studies
Obstetric monitoring and fetal assessment devices
Gynecological surgical systems (hysteroscopy, laparoscopy)
Contraceptive devices and systems
Pelvic floor disorder treatment devices
Breast health diagnostic and surgical devices
Design
We use innovative approaches — Bayesian design, adaptive clinical trial design, and Propensity Score Matching — to reduce costs, overcome limited data access, and minimize 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 – the good, bad, and ugly.”
• Vice President, Clinical Operations
Quality Through Listening
“They listen the first time. I’ve NEVER had to go back and re-spell out what I needed.”
”They work to understand the problem and leverage the information that is already there.”
• Former FDA Regulator
Why We Work With BSC
“GET STUFF DONE”
“They aren’t afraid to tackle difficult scenarios in compressed timelines.”
“When you have to do something no one else has done before.”
• CEO, Medical Device Company
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 – the good, bad, and ugly.”
• Vice President, Clinical Operations
Quality Through Listening
“They listen the first time. I’ve NEVER had to go back and re-spell out what I needed.”
”They work to understand the problem and leverage the information that is already there.”
• Former FDA Regulator
Why We Work With BSC
“GET STUFF DONE”
“They aren’t afraid to tackle difficult scenarios in compressed timelines.”
“When you have to do something no one else has done before.”
• CEO, Medical Device Company
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®
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®