The Next Steps to Modernize Clinical Trials with Digital Health Technologies and AI

The U.S. Congress has called for the modernization of clinical trials, and the FDA responded with its Framework for the Use of Digital Health Technologies (DHT) in Clinical Trials. This framework emphasizes using wearable, implantable, ingestible, and environmental sensors connected through mobile apps to capture and manage patient data remotely in real time. The goal is to improve trial efficiency and increase patient engagement.

The FDA’s framework also covers Software as a Medical Device (SaMD) and the growing role of artificial intelligence (AI) and machine learning (ML) in SaMD. These technologies support adaptive, learning-based models that become smarter over time by analyzing large volumes of clinical research data.

Crucial Data Solutions is already ahead of this modernization effort. Our platform, TrialKit, is the first and only mobile-first system with built-in connectivity to SaMD devices. It’s also the only solution in the industry that offers a single, self-configurable design tool that supports web and native iOS/Android apps across global servers.

With TrialKit, we deliver a mobile-first approach to Direct Data Capture (DDC) that includes virtual health monitoring, streamlined data management, and AI-powered reporting. This makes studies easier to manage while boosting patient engagement. We focus on patient-centered workflows—from screening and auto-enrollment to non-invasive data capture and long-term patient support.

Our platform modernizes traditional Electronic Clinical Outcome Assessment (eCOA) tools—which often rely on delayed, subjective data—by replacing them with real-time, objective diagnostic data. This is made possible through wearable devices that meet FDA 510(k) standards, paired with AI algorithms embedded directly into TrialKit. These advanced wearables include textile-based sensors that detect electrical, optical, thermal, and cellular signals, and transmit key endpoints to TrialKit from both human and animal subjects.

TrialKit supports Software-as-a-Service (SaaS) and Platform-as-a-Service (PaaS) models, helping researchers centralize and analyze data from preclinical work, core labs, and clinical trials. We’re also integrating endpoint diagnostic data to address the challenge of fragmented comorbidity data, especially in studies involving chronic conditions. Through our Data-as-a-Service (DaaS) offering, researchers and biostatisticians can use AI and ML to differentiate treatment effects from comorbidities using both descriptive and inferential analytics.

Crucial Data Solutions’ innovative approach to DHTs and AI is transforming clinical trials. By enabling real-time data capture and analysis, we reduce interpretation bias, lower patient anxiety, and minimize the disconnect between patients and clinical sites, ultimately lightening the load for both participants and healthcare providers.