Expanded Access Programs  provide investigational therapies to patients who are not eligible or able to participate in clinical trials but have serious or life-threatening diseases, for which their physician has determined there are no appropriate treatment options.

Many pharma/biotech offer investigational products and many investigators agreeing or insisting upon running multiple EAP trials for the benefit of their patient population who fail eligibility criteria of "regular" clinical trials.

Introduction of a regulatory-compliant platform to execute EAPs became a necessity.

The Center for Innovation and Bioinformatics (CIB) introduced the NeuroREACH™ platform to facilitate:

•  - Rapid deployment of EAP trials
•  - Capture of clinical and safety data from patients
•  - Data Management
•  - Real-time secure and controlled access to data visualization and reports

Any investigator 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.  

The NeuroREACH platform has been deployed at CIB and available to investigators and sponsors around the world.  Currently FOUR EAP trials utilize NeuroREACH. 

As patients may participate in multiple EAPs, NeuroGUIDs/NeuroSTAmPs are used to uniquely identify EAP participants across studies. Study sponsors and drug manufacturers have access to reports and dashboards to track enrollment data in real time.

As EAPs become more and more prevalent method to test investigational products for safety and even efficacy, the investigators and study sponsors may use NeuroREACH to rapidly deploy trials. The captured EAP information utilized by  pharma/biotech for new indications, safety analyses, and in negotiations with the FDA and insurance companies