Electronic Binder System for Clinical Trial Data Processing

ChangeBridge: Patent Grants - Health Informatics (G16H)

Published March 24th, 2026

Detected March 24th, 2026

Summary

The USPTO has granted a patent for an electronic binder system designed to process clinical trial source data into electronic data capture (EDC) systems. The system utilizes Natural Language Processing (NLP) to convert source data into machine-readable formats for improved data verification and auditing.

View original document View source feed page

What changed

The United States Patent and Trademark Office (USPTO) has granted patent US12586669B2 for an "Electronic binder system (ebinder) for processing source data to EDC systems." This patent covers a method and system for automatically processing clinical trial source data, including encrypting data, masking patient identifiable information, converting data into JSON and HTML formats using NLP, and populating EDC datasets. The system also provides side-by-side display of source and converted data for verification and auditing purposes.

This patent represents a new technological development in clinical trial data management. While it is a patent grant and not a regulatory rule, it may influence how clinical trial data is processed and managed in the future, potentially impacting compliance with data integrity and privacy regulations. Companies involved in clinical trials should be aware of this patented technology, particularly if developing or utilizing similar data processing systems. No immediate compliance actions are required, but it may inform future system development and data handling strategies.

Source document (simplified)

← USPTO Patent Grants

Electronic binder system (ebinder) for processing source data to EDC systems

Grant US12586669B2 Kind: B2 Mar 24, 2026

Inventors

Tai Xie, Richard Xue

Abstract

The present invention provides a method and system for automatically and seamlessly processing clinical trial source data into electronic data capture (EDC) systems. In one embodiment, a file structure is defined for an electronic binder system (eBinder); source data is uploaded to the eBinder; the source data is encrypted, Patient Identifiable Information in the source data is masked; the source data is converted into machine readable plain text in the JavaScript Object Notation (JSON) format using Natural Language Processing (NPL) technologies; the JSON data is converted into tabulated machine readable data in the HyperText Markup Language (HTML) format using NPL technologies; the HTML data is converted into machine understandable data using NPL technologies; the machine understandable data is populated into EDC datasets using NPL technologies; the source data and converted data are displayed side-by-side for source data verification; and a platform is provided for regulatory data verification or auditing.