# US20250111908A1: Digital Native Trials Management System

- Kind: Published application
- Family: Digital Native Trials Management System (https://www.intellectualfrontiers.com/patents/digital-native-trials-management-system)
- USPTO status: Final Rejection Mailed (as of 2026-08-27; record read 2026-09-27)
- Application: 18977822
- Filed: 2024-12-11
- Published: 2025-04-03
- Inventor: Shahid N. Shah
- Rights holder: Intellectual Frontiers LLC
- Classifications (CPC): G16H 10/20, G16H 40/67, G06Q 10/06315

## Licence or acquisition

Available for an exclusive or non-exclusive licence, field-of-use licences included, or for acquisition. Terms on inquiry. Write to hello+ip@intellectualfrontiers.com.

## Abstract

A system for autonomously managing an experimental study using real-world data. The system includes a processor that is configured to generate or receive an adaptive trial protocol defining participant criteria, one or more interventions, one or more outcomes, and respective durations. The processor is configured to facilitate recruitment of one or more participants via one or more digital channels based on assessment of eligibility against the participant criteria. The processor is configured to continuously analyze the real-world data associated with the one or more participants for one or more of adaptive trial adjustments, anomaly detection, and outcome generation.

## Independent claims

1. An adaptive software-as-a-service (SaaS)-based system for autonomously managing an experimental study using real-world data, the system comprising: a processor to: generate or receive a trial protocol defining participant criteria, one or more interventions, one or more outcomes, and respective durations; facilitate recruitment of one or more participants via one or more digital channels based on assessment of eligibility against the participant criteria; and continuously analyze the real-world data associated with the one or more participants for one or more of adaptive trial adjustments, anomaly detection, and outcome generation.

10. An adaptive software-as-a-service (SaaS)-based digital system for conducting an autonomous experimental study using real-world data, the system comprising: a processor to execute machine-readable instructions stored on a non-transitory computer-readable medium, wherein the processor is to: one of either receive, from a user interface, a trial protocol specifying one or more of participant recruitment criteria, intervention types, outcome measures, and trial duration, or autonomously generate the trial protocol by applying one or more machine learning algorithms to analyze historical study data and multi-dimensional input criteria; facilitate recruitment of one or more participants by integrating with one or more digital channels, including one or more of a mobile application, a wearable device, and a social networking server; dynamically assess participant eligibility by processing at least one of real-time physiological measurements and participant-reported inputs; automatically enroll the one or more participants into the experimental study when their data satisfies the participant recruitment criteria specified in the trial protocol; and execute computational models for analyzing the real-world data during the experimental study to generate one or more trial outcomes.

12. A method for autonomously managing an experimental study using real-world data through an adaptive software-as-a-service (SaaS)-based system, the method comprising: generating or receiving a trial protocol, wherein the trial protocol specifies participant criteria, one or more interventions, an outcome, and a duration of the experimental study; assessing eligibility of the one or more participants against the participant criteria specified in the trial protocol; facilitating recruitment of the one or more participants through one or more digital channels; and continuously analyzing the real-world data associated with the one or more participants during the experimental study to perform one or more of adaptive trial adjustments, detecting one or more anomalies, and recording one or more outcomes.

Source: https://www.intellectualfrontiers.com/patents/digital-native-trials-management-system/us20250111908a1