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BSC® Therapy Areas
Clinical Depth Across Specialties
Neurology & Pain Management
BSC supports both established neurostimulation technologies and emerging neurological interventions with the rigorous statistical approaches and regulatory foresight needed to navigate subjective endpoints, demonstrate clinical benefit, and achieve market access in this innovative therapeutic area.
General Surgery & Minimally Invasive Devices
BSC supports surgical device manufacturers with statistical strategies that demonstrate procedural benefit while addressing FDA's safety expectations. From robotic systems to minimally invasive instruments, we help you build compelling evidence for both regulatory approval and clinical adoption.
Cross-Cutting Therapeutic Capabilities
BSC leverages sophisticated approaches like propensity score analysis to address real-world evidence challenges, minimize bias, and build more persuasive regulatory narratives. Our nearly 40 years of FDA experience translates across all device categories, delivering regulatory success from early feasibility through post-market surveillance.
Ophthalmology
BSC delivers regulatory-ready statistical strategies for ophthalmic devices, addressing FDA's specific expectations for visual endpoints and bilateral data. Our approach minimizes regulatory risk while maximizing your clinical evidence's persuasive power.
Cardiovascular Devices
BSC brings proven cardiovascular trial experience to support your FDA strategy, from early feasibility through PMA approval. Our regulatory insight helps you anticipate FDA questions, optimize endpoint selection, and build compelling evidence packages for transcatheter valves, vascular interventions, and cardiac rhythm devices.
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.
Diabetes & Endocrinology
We support continuous glucose monitors, insulin delivery systems, and metabolic devices through FDA's evolving regulatory landscape. BSC's comparative effectiveness expertise and real-world evidence capabilities position your device for both regulatory approval and market differentiation.
Diagnostics & Laboratory Medicine
BSC brings established regulatory expertise to help you achieve FDA clearance or approval efficiently. Our capabilities in diagnostic accuracy studies, clinical validation, and CLIA compliance position your technology for successful market entry and payer acceptance.
Oncology
Cancer device trials demand sophisticated survival analyses and compelling benefit-risk narratives. BSC's regulatory experience helps you build the evidence strategy FDA expects, positioning your device for approval in this challenging therapeutic area.
Orthopedics & Spine
With nearly 40 years supporting orthopedic and spine device manufacturers, BSC has established unmatched regulatory expertise in musculoskeletal research. We've guided spinal fusion systems, joint replacements, and fracture fixation devices through complex FDA pathways, delivering efficient approvals and defensible statistical strategies.
Respiratory & Sleep Medicine
BSC's published research in sleep medicine reflects deep domain knowledge in polysomnography endpoints and respiratory assessments. We translate this expertise into regulatory strategies that anticipate FDA expectations and accelerate your path to approval for ventilators, sleep apnea devices, and respiratory diagnostics.
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 FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
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