Alcedis – a Huma company, and Samsung Announce Partnership to Advance Biomarker Development and Clinical Endpoints from Early-Phase Research to Real-World Evidence

Exclusive access to Samsung’s research platform enables protocol-aligned biosensor data capture, raw signal access, and end-to-end study execution, setting a new standard for wearable-based clinical evidence generation.

• Alcedis and Samsung enter a partnership granting Alcedis access to Samsung’s sensor programming framework — enabling device-level control, full sensor configuration, and raw biodata extraction across Samsung wearables.
• Sponsors gain full access to biosensor signals from Galaxy Watch, moving far beyond conventional consumer wearable data at summary level to deliver clinically meaningful, continuous biosensor data required for digital endpoints, biomarker algorithms, and regulatory-ready evidence.
• This partnership delivers an end-to-end evidence-generation ecosystem for study design, data infrastructure, clinical operations and analytics to enable accelerated study execution with higher-quality data collection.

Frankfurt, Germany, Jun. 24, 2026 — Samsung Electronics Co., Ltd., and Alcedis, a Huma company, the leading digital first CRO, announced at the 9th Annual Digital Biomarkers in Clinical Trials Summit in Basel, Switzerland a partnership to transform how biosensor data is collected, managed, and analyzed in clinical trials.

The rapid growth of digital biomarkers and patient-facing technologies is creating significant demand for richer, more flexible data access. This trend is strongly supported by regulatory agencies that increasingly recognize and anticipate digital health technologies as part of drug development as healthcare delivery shifts toward decentralized and outpatient care models.

In traditional trial settings, wearable devices operate largely as black boxes. Researchers receive pre-processed outputs with limited visibility into the underlying data. Available SDK outputs, pre-defined consumer scores, and limited APIs have historically forced protocol design to adapt to what the technology could deliver, rather than what science required.

This collaboration is transformative for clinical research as Alcedis gains singular access to Samsung’s research platform, enabling Alcedis and study sponsors to control individual Samsung wearable devices at the protocol level, configure all onboard sensors around the research question itself, defining which sensors are active, when measurements occur, at what frequency, and for which individual participants.

This new partnership will create value across the entire asset lifecycle creating a bridge from R&D through commercialization as biomarker programs and algorithms developed in early phase and post-approval research can be commercially launched at global scale into healthcare delivery via Huma’s Cloud Platform (HCP) in Software as Medical Device (SaMD) grade.

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Key Capabilities Enabled by the Partnership

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.

• Protocol-aligned biosensor capture: Full control over device configuration and measurement timing at the individual participant level, replacing generic consumer summaries with study-specific, research-question-driven data acquisition.
• Raw signal access: Direct extraction of raw or near-raw biosensor data, increasing data depth, sensitivity, and completeness for advanced biomarker development, algorithm training, and endpoint validation.
• End-to-end CRO execution: Comprehensive study support spanning endpoint design, device logistics, participant onboarding, site enablement, training, compliance monitoring, data flow, analytics, and sponsor-ready outputs — all within a single integrated delivery model.
• Audit-ready traceability: Fully traceable data pipelines and documented workflows, built for sponsor review, regulatory inspection, and validation requirements in line with FDA and EMA expectations for digital endpoint evidence.
• Scalable deployment across the lifecycle: A flexible architecture accommodating exploratory pilot studies, biomarker validation programs, registries, and post-market evidence generation — designed to grow with the asset rather than be rebuilt for each phase.
• Asset value for R&D and medical teams: Raw data retention enables post-hoc analysis, supports label expansion or reimbursement discussions, and creates a foundation for digital companion or therapy-support programs — extending value far beyond the trial itself.

Leadership Perspectives

“The future of clinical research is increasingly collaborative, bringing 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. “Samsung’s approach combines wearable technology, scientific expertise, and research-related technical  infrastructure to help transform data into meaningful evidence. Through collaborations with CROs like Alcedis, we’re helping pharmaceutical and other research organizations unlock new opportunities for biomarker development, digital endpoint innovation and evidence generation throughout the research lifecycle.”

“The pharma industry has been asking for exactly this: a wearable solution that does not force protocol design to adapt to the technology but instead lets the research question and protocol drive the data”, says Managing Director of Alcedis, Hanno Härtlein. “Our partnership delivers that with the operational backbone that sponsors need to run streamlined studies at scale. This is how we turn biosensor capabilities into real clinical value.”
 

About Alcedis – a Huma Company

Alcedis GmbH is a full-service digital first contract research organization (CRO) headquartered nearby Frankfurt, Germany, with deep expertise in clinical research, biotech, and clinical development. Alcedis partners with sponsors across the pharmaceutical, medical device, and digital health industries to design, execute, and deliver clinical studies of the highest scientific and regulatory quality. With over 30 years of experience in clinical research Alcedis combines in-depth clinical trial expertise with state-of-the-art digital solutions, including AI-powered platforms and automated data integration, to efficiently and accurately conduct research – from Phase I to market authorization and into real-world evidence. Alcedis is part of the Huma group.

About Huma

Huma is a global healthcare AI company accelerating the adoption of digital and AI across care and research. The Huma Cloud Platform is the company’s foundational technology, enabling healthcare providers, governments, and life sciences organizations to rapidly build, deploy, and scale regulated digital health and AI solutions. Huma supports nearly 100 million patients globally and powers healthcare transformation initiatives across more than 70 countries.