Expanded Access eRequest Platform for the FDA

The Challenge

The primary challenge was to get reviews and approvals from many stakeholders for every decision and functionality of the app. BTC team had to consider requirements from the physician’s point of view and those from the FDA leadership, the legal team, and the various groups* who were part of the EA intake and response process. The teams would provide feedback to BTC during every review session. 

* Legal teams, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and the Oncology departments of the FDA.

Other challenges for BTC were:

• Understand the nuances of this entire process and the priorities of the stakeholders – the physicians and multiple teams at the FDA.
• Create a faster and user-friendly way for physicians to request the EA and review groups to accept and approve the applications.
• Build a solution that would protect sensitive patient data and follow healthcare industry standards.

The Solution

• BTC analyzed the client processes and organizational infrastructure extensively. The BTC team operated as an ancillary arm of the FDA for the project. 
• We undertook a current state analysis, covering the application and review process, including the political landscape and legal concerns around HIPAA, PHI, and PII data.
• BTC developed the first-of-its-kind web application called the ‘Expanded Access eRequest’ to seamlessly guide physicians through the complicated process of submitting initial expanded access IND applications to the FDA and follow up documents online.  
• A corresponding administrative console web app was built for FDA and RUF staff to review and address submitted applications and manage the other associated administrative functions.
• Both the web apps were compatible across browsers and devices, allowing physicians and federal officials to access the app on any device. 
• The app connects with ClinicalTrials.gov and RUF Company Navigator using API Integration to streamline the process of compiling relevant information for the IND application. 
• A step-by-step guide was provided to help physicians use the above-mentioned companion sites for determining whether a clinical trial was available and could be leveraged.
• The platform (a suite of web apps) prevented undue exposure of sensitive information by adhering to industry regulations, including HIPAA, 21 CFR Part II, and FISMA grade security controls. 
• BTC provided customer support, technical support, and hosting and infrastructure support.

The Outcome

• Through the app, physicians could digitally submit the initial EAP IND applications known as Form FDA 3926 to the FDA. It also enabled them to review and track the applications online.
• BTC’s application eliminated the paper-based processes, which significantly speeded up the entire request and approval process for EAP, helping save more lives faster.
• The new web applications ensure the scalability, efficiency, and extensibility of the EAP. 
• Users could check information on active clinical trials, investigational product company’s contact information, and instructions for requesting access to the investigational therapy and obtaining informed patient consent.