Sensors & Wearables

Signant Health's Sensors & Wearables solution is designed for clinical trial sponsors, investigators, and research teams seeking to capture objective, real-world data beyond routine clinic visits. Integrated within the Signant SmartSignals platform, this solution combines wearable devices and mobile health sensors with eCOA technology to deliver deeper insights into patient health, treatment effects, and real-world functioning.

By reducing the burden on patients and sites while improving data completeness and endpoint reliability, Signant SmartSignals Sensors & Wearables enables more rigorous, patient-centric clinical research — including fully virtual study designs.

Core Capabilities

• Observe real-world behavior: Integrated wearable and sensor technology provides valuable insights into real-world functioning, enabling a greater understanding of treatment effects outside of clinical settings.
• Simplify use for patients and sites: When combined with eCOA, devices streamline set-up and data collection activities, minimising complexity for both patients and site staff.
• Drive endpoint accuracy: Data-driven notifications alert patients who are failing to wear their device, reducing missing data, producing more complete datasets, and supporting more reliable clinical endpoints.
• Remote patient monitoring: The platform enables sponsors to remotely monitor patient safety, understand real-world behaviour, collect data at more frequent intervals, and conduct virtual studies.

Integration with Signant SmartSignals eCOA

• Single platform approach: Sensors & Wearables is fully integrated with Signant SmartSignals eCOA, simplifying data collection workflows across the study.
• Better patient oversight: Investigators and sponsors can review sensor data and eCOA data together in a unified interface, enabling integrated, real-time review of each patient's health status.
• Endpoint quality: The combined platform drives endpoint quality through data-driven notifications and reminders that proactively prevent missing data.

eCOA Platform Features

• Instrument library: Signant's library contains over 50 instruments commonly used in clinical trials, many available as pre-approved, pre-validated versions that do not require additional testing when implemented in a new study, saving time and ensuring quality.
• Computerized Adaptive Tests (CATs): Signant SmartSignals eCOA supports implementation of PROMIS CAT alongside conventional PROMs, with more than 20 domains available including anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and social function.
• Scientific consulting: Signant provides expert scientific and clinical consulting to support eCOA strategy, regulatory navigation, and electronic implementation, combining advanced technology with deep domain expertise to protect data quality throughout the trial.

Understanding eCOA and Related Technologies

• eCOA (Electronic Clinical Outcome Assessment) uses technology to accelerate clinical data collection and ensure data quality, giving sponsors near real-time understanding of how patients feel and function.
• ePRO (Electronic Patient-Reported Outcome) is a subset of eCOA, where patients use mobile devices to remotely report symptoms and experiences directly to site staff.
• Other COA types supported include Electronic Performance Outcome (ePerfO), Electronic Clinician-Reported Outcome (eClinRO), and Electronic Observer-Reported Outcome (eObsRO).

Signant SmartSignals Sensors & Wearables is built for teams looking to enhance endpoint data, enable remote and virtual trial models, and gain a more complete picture of patient health. Sponsors and investigators can engage Signant's science and sensor integration teams to discuss protocol-specific requirements and explore how the platform can meet their study objectives.