A scalable infrastructure for digital biomarker development and digital endpoints
Alcedis – a Huma Company, and Samsung announce a strategic partnership to advance biomarker development and clinical endpoints from early-phase research to Real-World Evidence
A scalable biosensor infrastructure, built on the devices your patients already wear
Alcedis – a Huma company, and Samsung combine 30+ years of clinical research expertise with access to Samsung's research platform to configure each device sensor to your study protocol. As your Digital Endpoint Provider, we form one end-to-end evidence-generation ecosystem, beyond device provision, helping sponsors generate, manage, and leverage wearable-derived evidence across the entire development lifecycle. Deeper data. Cleaner capture. Evidence you can build on.
Designed around the research question – not device limitations
Demand for digital biomarkers is growing over 20% a year through 2030. But adoption was never the hard part – generating valid, validated evidence is. Consumer SDKs and pre-defined scores force your protocol to adapt to the device. The Samsung–Alcedis partnership flips that: the protocol drives the data, raw signals stay accessible for re-analysis, and one accountable team turns continuous biosensor streams into sponsor-ready datasets – from first-in-human to real-world evidence and commercial use.
Proven at Scale
10,000 participants, monitored continuously
Samsung wearables already power the HEARTBEAT study – a landmark cardiovascular trial run by Tulane University, Samsung and Alcedis. Each of its 10,000 participants wears a Samsung smartwatch for continuous cardiac monitoring, with advanced analytics applied to the biometric data to detect patterns that precede cardiovascular events – laying the groundwork for earlier, more personalized prevention. Further studies are already in preparation across a bandwith of therapeutic areas with global top 10 pharma companies.
Capture the Full Signal
Faster Execution, Better Quality
Scale into Pharma Asset Value
Capture the full signal, not summaries
- Protocol-defined sensor selection, timing, and frequency – down to the individual participant
- Raw and near-raw biosensor signals – tailored to the scientific objective, not fixed manufacturer SDK outputs or consumer scores
- Direct access through Samsung's research platform
- Greater data depth, sensitivity, and completeness for biomarker development and endpoint validation
- Capture cadence aligned to your endpoints and analysis plan
Turn raw signals into evidence
- End-to-end, CRO-led execution with rapid deployment – sensor configuration and device set-up in under 6 weeks.
- Continuous monitoring of adherence, wear time, and data completeness
- Quality oversight with near-real-time issue resolution
- Fully traceable data pipelines, built for sponsor review and regulatory inspection
- Aligned with FDA and EMA expectations for digital endpoint evidence
Scale from first-in-human to real-world evidence
- One continuous data strategy across early phase, late phase, post-approval, and commercial care – a bridge from R&D to commercialization
- Future-proof your evidence: retain raw sensor data for post-hoc analysis, new endpoints, and label-expansion discussions
- Programs to lower patient burden
- Biomarker algorithm (co-)development and global regulatory cleared SaMD-grade deployment via the Huma Cloud Platform
Ready to turn biosensor data into evidence?
Let's talk about your indication, your endpoints, and your study timelines.