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.