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
Neurology & Pain Management
Delivering expertise in an expanding therapeutic area
Neurology & Pain Management
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.
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®