Frankfurt, Germany / Mountain View, USA - June 24, 2026 - Samsung Electronics Co., Ltd., and Huma Alcedis, the leading digital first CRO, today 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. 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.

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.

Key Capabilities Enabled by the Partnership

• 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.