What is NeuroREACH™?
NeuroREACH™ is a regulatory-compliant platform for Expanded Access Program (EAP) trials that facilitates:
Rapid deployment of single site or multi-sites EAP trials
Capture of clinical and safety data from patients
Real-time secure and controlled access to data visualization and reports
As patients may participate in multiple EAPs and other observational studies, NeuroGUIDs / NeuroSTAmPs are used to uniquely identify EAP participants across resources. Study sponsors and drug manufacturers have access to reports and dashboards to track enrollment data in real time.
Any investigator/sponsor with an IRB-approved EAP protocol and open enrollment of patients may capture and store phenotypical, safety, and biomarker data utilizing the NeuroREACH™ EDC platform. The CIB acts as the Data Coordination Center and its program management team will oversee the addition of new studies, data curation, visualization, and reporting.