Regulatory strategy for reproductive and maternal health innovations
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.
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