Digital Health
Technologies
Powered by Ametris, a Signant Health Company
What patients say.
What their bodies show.
Signant Health has aquired Ametris, bringing together the leading clinical outcome assessment platform with premier wearable sensor technology. One partner for clinical outcome assessments and sensor-based digital measures, coordinated from endpoint strategy through regulatory submission.
The future of clinical evidence generation is available today. Hear from CEO Roger Smith on what the Ametris acquisition means for your trials.
One Partner. One Strategy.
Clinical trials increasingly require multiple lines of evidence to demonstrate meaningful treatment benefit. Clinical outcome assessments - including patient-reported outcomes, clinician ratings, and cognitive testing - capture how patients feel and function in their daily lives, what matters most to patients and regulators. Sensor-based digital measures capture continuous, real-world data on movement, sleep, vital signs, and other physiological parameters between clinic visits.
Together, they provide complementary perspectives that strengthen efficacy cases and support more confident decision-making.
With Signant Health's acquisition of Ametris, sponsors now have one partner for both modalities, backed by deep scientific and regulatory expertise across both domains.
About Ametris
Ametris (formerly ActiGraph) brings two decades of pioneering leadership in wearable sensor technology for clinical research. Their data appears in over 30,000 peer-reviewed publications and has established regulatory precedent at FDA, EMA, and agencies globally across CNS, cardiovascular, oncology, and respiratory programs.
The Ametris platform is device-agnostic, supporting both proprietary sensors (including the ActiGraph LEAP® multi-sensor wearable) and validated third-party devices across activity, sleep, cardiac, respiratory, gait, and vital signs monitoring. AI-powered analytics transform raw sensor data into regulatory-grade digital endpoints with full scientific and operational support.
Ametris is trusted by pharmaceutical and biotech companies worldwide for delivering validated, regulatory-ready DHT solutions.
Therapeutic Areas
real-world function is central to the evidence case, including:
CNS (Neurology & Psychiatry)
Oncology &
Immuno-Oncology
Respiratory
Immunology & Rare Disease
Cardiovascular &
Metabolic
Dermatology
Comprehensive Regulatory and Scientific Expertise
Signant Health
Signant has supported hundreds of regulatory submissions with clinical outcome assessment endpoints across diverse therapeutic areas, trusted by all Top 20 pharma and over 600 sponsors globally. Signant's solutions have been used in 25% of novel drug approvals at FDA and EMA from 2021 to 2024.
Ametris
Ametris has deployed solutions in 285+ industry-sponsored clinical trials across 150+ countries globally. Their FDA-cleared, medical-grade devices have generated evidence published in 30,000+ peer-reviewed scientific publications, and supported clinical development submissions across a broad range of therapy areas.
FAQs
What is digital health technology (DHT) in clinical trials?
Digital health technology refers to sensor-based devices and software that capture real-world data from patients during clinical trials. This includes wearables, home monitoring devices, and connected sensors that measure activity, sleep, gait, cardiac function, respiratory measures, vital signs and other physiological data between clinic visits. DHT data complements clinical outcome assessments by providing additional insights into how patients function in their daily lives.
How does Ametris work with Signant's clinical outcome assessments?
Signant Health and Ametris provide sponsors with one partner for both clinical outcome assessments and DHT. Clinical outcome assessments and sensor-based endpoints are coordinated as one evidence strategy from protocol design through regulatory submission, with combined scientific and regulatory expertise available immediately. As platform integration develops, sponsors will benefit from unified datasets, integrated analytics, and streamlined workflows.
What therapeutic areas benefit most from combining clinical outcome assessments and DHT?
DHT adds particular value where real-world function is central to the evidence case. CNS programs benefit significantly from continuous activity, sleep, gait, and motor function data alongside patient-reported endpoints. Oncology, respiratory, cardiovascular, metabolic, immunology, and rare disease programs also benefit, particularly where real-world functional outcomes matter to regulators and payers.
What is Ametris's track record in clinical research?
Ametris (formerly ActiGraph) is the most established clinical-grade DHT platform in regulated research. Their data appears in over 30,000 peer-reviewed publications with established regulatory precedent at FDA, EMA, and agencies globally. The platform is device-agnostic, supporting proprietary and validated third-party sensors, with AI-powered analytics and comprehensive scientific and operational services.
Can Signant implement computerized adaptive tests (CATs)?
Yes. Signant SmartSignals eCOA includes the ability to implement the PROMIS CAT seamlessly alongside conventional PROMs. Choose from more than 20 domains including anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and social function. For more information, read our PROMIS CAT brochure and white paper.