Digital Health Technology (DHT)
Advancing Clinical Research Through Digital Health Technologies
Digital health technologies are fundamentally reshaping how clinical trials are designed, conducted, and experienced by participants. For nearly 10 years, THREAD has pioneered the use of 510k cleared/CE mark approved medical devices and consumer wearables in global clinical trials. We estibalished the approached, supported the development of the regulations and provided the published case studies to move DHT from innovation projects to mainstream clinical trial use.
Validated sensors, wearables, and remote monitoring tools are no longer emerging innovations. They are evidence-generation instruments that regulators, sponsors, and payers increasingly rely on to understand how therapies perform in the real world. Deploying DHTs effectively requires more than a technology integration. It demands scientific rigor, regulatory fluency, pre-built integration experiences and a platform purpose-built to capture, manage, and contextualize the data they generate. THREAD has partnered with biopharma sponsors, CROs, and medical/consumer device companies globally to design and execute DHT-enabled studies that deliver high-quality, regulatory-grade evidence at scale.
A Platform Engineered for DHT-Enabled Data Capture
THREAD's configurable, full-featured clinical research platform is built to support the complexity of multi-modal data collection across decentralized, hybrid, and site-based clinical trial models. Our validated integrations with leading sensors, wearables, and connected devices enable active, passive, or continuous real-world data capture. This seamless approach for research sites and patients reduces participant burden while expanding the depth and frequency of evidence collected. Included as a feature within the overall platform, THREAD delivers a unified data environment where DHT-generated endpoints sit alongside clinician and patient reported data in a single, audit-ready record.
The THREAD platform holds the Digital Medicine Society (DiMe) Seal of Validation as an inaugural recipient, providing sponsors and regulators with independent confirmation that our DHT deployment processes meet the highest standards for scientific and operational quality.
Consulting Services Designed for DHT Integration and Validation
Successfully incorporating digital health technologies into a clinical program requires strategic planning long before the clinical trial is live for enrollment. THREAD's consulting team brings deep expertise in DHT selection, sensor validation, endpoint qualification, and operational implementation to every engagement.
Our consultants work alongside sponsors and CROs to identify the right technologies for each indication and protocol, define fit-for-purpose data collection strategies, and ensure that DHT-derived endpoints meet global regulatory expectations. THREAD provides the scientific and operational guidance needed to deploy digital health technologies with confidence and generate the real-world evidence that matters most for patients, providers, and payers.
