Expanded Access eRequest Web Application

ea erequest application

EA eRequest Application

ea erequest application
ea erequest application
ea erequest application
ea erequest application
ea erequest application
ea erequest application
ea erequest application

The Challenge

The U.S. Food and Drug Administration (FDA), in collaboration with the Reagan-Udall Foundation (RUF), identified a critical need to improve the process by which non-emergency Individual Patient Expanded Access Investigational New Drug (IND) applications are prepared, submitted, and tracked. This pathway allows patients with serious or life-threatening conditions to gain access to investigational treatments when no satisfactory alternatives exist.

Historically, the application process for Expanded Access INDs has been burdensome and time-consuming for physicians and patients alike, often involving manual forms and unclear submission pathways. Recognizing this challenge, the FDA and RUF sought a digital solution to streamline and modernize the process.

Objectives

  • Streamline and digitize the Expanded Access request process
  • Enable efficient document management and user communication
  • Ensure compliance with FDA standards and federal regulations
  • Create a scalable, secure, and intuitive platform for internal and external users
  • Gathers resources into one place
  • Walks users step-by-step through process

The Solution

RUF and the FDA launched a secure, user-friendly, web-based application to simplify the preparation, submission, and tracking of non-emergency Individual Patient Expanded Access IND applications.

The Expanded Access eRequest platform is a web and mobile site that helps physicians determine whether Expanded Access is appropriate for their patients, walks physicians through the process of completing Form FDA 3926 and submitting it to FDA, provides a single site for uploading relevant documents, and offers useful links and resources.

After launch of the application, TrazerEdge continued on as the technical partner to provide all maintenance, support, development and enhancement of the EA eRequest platform.

Key Features

User Roles & Access Levels

  • External Users: Physicians, Sponsors, and Coordinators
  • Internal Users: FDA Reviewers, Administrators
  • One-time registration collects physician information that is used for all Expanded Access requests

Submission and Review Workflow

  • Online submission of Expanded Access requests
  • Auto-populate FDA Form 3926
  • Automated routing to appropriate FDA offices based on case type
  • Review tracking with confirmation, timestamps, statuses, and comment history

Dashboard & Notifications

  • Custom dashboards for each user type
  • Automated alerts for action items, updates, and communication

Document Management

  • Upload, download, and version control of supporting documents
  • Secure storage with audit trails

Integration

Security & Compliance

  • FedRAMP and FISMA compliance
  • Secure data transmission (SSL), multifactor authentication, and audit logging

Technical Stack

  • Cloud-hosted solution with Amazon Web Services (AWS)
  • Modular architecture with RESTful APIs
  • Application stack:
    • Java for web application
    • Angular for web frontend
    • PostgreSQL server
    • JBOSS Wildfly
    • Spring boot framework
    • Jenkins for deployment