Delivering expertise in an expanding therapeutic area
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.
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.