Navigating Neurology Clinical Trials with Confidence

As a neurology CRO, we implement tiered informed consent approaches incorporating capacity assessment tools, simplified informed consent documents, and include a legally authorized representative (LAR) when appropriate. Our approach includes ongoing capacity monitoring, LAR procedures for participants with impaired capacity, and specialized training for study staff on ethical enrollment of vulnerable populations.

We implement comprehensive rater training programs with certification requirements, standardized testing environments, and centralized quality oversight of assessment data. Our approach includes video review of assessment administration, frequent reliability checks, and real-time feedback systems to maintain consistent evaluation standards throughout studies.

Our teams develop custom validation strategies incorporating traditional clinical anchors, test-retest reliability assessment, and correlation analyses with established neurological measures. We implement specialized data collection protocols, signal quality verification processes, and innovative statistical approaches to establish the validity of novel neurological measurements.

We have extensive experience implementing remote assessment for cognitive function, movement disorders, and neurophysiological monitoring. Our approach addresses unique considerations for caregiver assistance, simplified user interfaces, and modified administration procedures to enable successful remote neurological technology evaluation across varying patient capabilities.

We implement validated caregiver-reported outcome measures with standardized training for consistent reporting, clear distinction between objective observation and subjective interpretation, and appropriate statistical approaches for incorporating caregiver data. Our protocols define specific caregiver qualifications, required interaction levels, and structured reporting timeframes to ensure reliable supplemental assessment data.