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.
Overview
BSC provides specialized statistical support for neurological devices and pain management technologies, including neuromodulation, neurovascular interventions, and diagnostic devices. Our experience spans acute and chronic conditions affecting the nervous system.
Specialized Capabilities
Complex pain endpoint modeling (VAS trajectories, responder analyses). Handling of crossover designs is common in pain trials. Sham control considerations and blinding strategies. Modeling of neurological function scores (NIHSS, mRS, GCS). Long-term durability assessment for neurostimulation devices.
Regulatory Experience
We understand FDA expectations for subjective outcome measures in pain studies, including appropriate validation, missing data handling, and multiple imputation strategies. Our team has navigated challenging discussions around sham controls, patient expectation effects, and long-term safety monitoring.
Representative Studies
Spinal cord stimulation for chronic pain. Deep brain stimulation devices. Neurovascular intervention devices (stroke, aneurysm). Peripheral nerve stimulation systems. Neurodiagnostic and monitoring 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
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