SammariHealthAI builds AI-driven wearable devices that monitor clinical trial patients around the clock — streaming vitals, ECG, and glucose data directly into sponsor EDC and patient EMR systems.
Today, a patient in a Phase III trial is monitored every 4–8 weeks at scheduled clinic visits. In between, nobody is watching — and that is where patients deteriorate, adverse events occur, and billion-dollar trials fail.
Patient receives wearable at enrollment. Monitoring begins immediately — not at the next clinic visit.
Every heartbeat, glucose reading, blood pressure, and temperature captured in real time — at home, at work, while sleeping.
Our AI engine analyzes the stream in real time and flags anomalies — arrhythmias, glucose spikes, vital deviations — before they become adverse events.
Every data point routes directly into Medidata, Oracle, or Veeva EDC and Epic or Cerner EMR — zero manual data entry, full 21 CFR Part 11 audit trail.
A medical-grade wearable platform and AI intelligence layer that replaces periodic monitoring with continuous, always-on patient surveillance — fully integrated with existing clinical trial infrastructure.
Single-lead ECG patch with AI-powered arrhythmia detection. Identifies QTc prolongation, AFib, and other cardiac safety signals in real time — not weeks later.
Continuous glucose monitoring 24/7 for metabolic disease trials. Alerts for critical highs, lows, and trending deviations. Full integration with CGM biosensors.
Heart rate, SpO₂, blood pressure, body temperature, and respiration rate — all captured continuously in a single lightweight wristband worn 24 hours a day.
FHIR R4 API connects directly to Epic, Cerner, and Athena. CDISC ODM-XML auto-populates CRF fields in Medidata Rave, Oracle Clinical One, and Veeva EDC — zero manual re-entry.
Machine learning models trained on clinical trial safety patterns detect anomalies, predict dropout risk, and generate alerts to investigators — before events escalate.
21 CFR Part 11 compliant audit trail. HIPAA & HITECH data security. ISO 13485 / FDA QMSR quality system. IEC 62304 software lifecycle. Built for FDA submission from day one.
Five seamless layers connect the wearable device to regulatory-grade clinical trial data — automatically, securely, and in real time.
Bringing a new drug to market takes 12–15 years and costs up to $8 billion. SammariHealthAI reduces cost and time in the three phases that matter most.
Only 1 in 10 drug candidates that enter clinical trials ever reach market. A single 3-month trial delay costs sponsors $40–80 million. SammariHealthAI's continuous monitoring platform prevents the safety gaps and data failures that cause those delays — reducing total trial costs by 20–40%.
Global market by 2030
Global market by 2030
Annual market size
Phase I–III monitoring
Combined 80+ years of clinical trials, pharmaceutical operations, medicine, and healthcare leadership experience.
Whether you're a pharma sponsor, CRO, medical group, or investor — we'd love to talk. Request a demo, discuss a pilot, or explore a partnership.