Women's Health
BSC® understands the unique regulatory and clinical considerations in women's health devices. We help you navigate FDA's heightened safety expectations while building efficient pathways to approval for fertility technologies, maternal health devices, and gynecological interventions.
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
Gynecological surgical systems (hysteroscopy, laparoscopy)
Obstetric monitoring and fetal assessment devices
Contraceptive devices and systems
Pelvic floor disorder treatment devices
Breast health diagnostic and surgical devices
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.
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