Samsung Partners With Alcedis to Advance Clinical Research Using Wearable-Based Endpoints

Samsung Electronics Co., Ltd. today announced a partnership with Alcedis, a digital first clinical research organization (CRO) specializing in data-driven clinical trials, to translate biometrics collected by wearable devices into meaningful evidence for clinical trials in pharmaceutical and other research organizations, maximizing efficiency in terms of both cost and time.

Wearable technologies have become a widely available and cost effective way to capture continuous, real-world health data, making them extremely appealing for clinical research. However, many research programs struggle to translate wearable-generated signals into clinically meaningful evidence.

Samsung addresses this challenge through an integrated approach that combines its latest advancements in wearable technology with sensors, including blood oxygen (SpO2) measurement, as well as Software as Medical Device (SaMD) features such as sleep apnea (OSA), ¹  ECG and Atrial Fibrillation (AFib) ²  detection, biomarker development expertise, and research-related technical infrastructure designed to support evidence generation across the research lifecycle.

“The future of clinical research is increasingly collaborative and brings together technology, scientific expertise and research partners to generate a deeper understanding of human health,” said Jongmin Choi, Head of Health R&D Group, Mobile eXperience (MX) Business, Samsung Electronics. “Through our collaboration with Alcedis, Samsung is unlocking new opportunities for biomarker development, digital endpoint innovation and evidence generation — throughout the research lifecycle.”

Samsung’s research platform starts with its cutting-edge devices and biosensors featured on Galaxy Watch that enable continuous collection of physiological data in real-world environments for users that have consented. With innovative wearable technology and a collaborative approach developing measurement methodologies that provide a foundation for digital biomarkers and endpoints, Samsung’s research platform allows for faster study setup with fine-grained control of biosensors and access to participant and device level insights and biosensor data with respect to the study and established protocols.

As healthcare shifts toward more connected, data-driven models of care and research, Samsung is helping bridge the gap between everyday health monitoring and scientific discovery — enabling a new era of evidence generation that brings researchers closer to real-world insights and helps accelerate innovation across the healthcare ecosystem.

“The future of clinical research depends on our ability to capture meaningful health data beyond traditional clinical settings,” said Hanno Härtlein, CEO, at Alcedis. “Our collaboration with Samsung brings together complementary strengths and scalable infrastructure to help advance endpoints and biomarker development, to accelerate evidence generation and support the development of more patient-centric healthcare innovations.” Under our collaboration, Alcedis will lead study execution and participant engagement, while Samsung will provide its advanced wearable technology and research infrastructure to support evidence generation.

¹ The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.

2 The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.