$3.7M
Series A (2019)
Company Profile
Health · Real-World Evidence · New York
Embleema
The platform that turns scattered health records into evidence regulators can trust.
The platform that turns scattered health records into evidence regulators can trust.
Clinical research runs on data that rarely fits together. A patient's records sit in a hospital system, their genomics in a lab, their day-to-day symptoms on a phone, and their consent on a paper form in a filing cabinet. Embleema, a healthcare technology company headquartered in New York with deep roots in France, was built to collapse those silos into a single, source-tracked dataset that regulators will accept.
The company describes its product plainly: an end-to-end real-world data and evidence platform that unifies clinical, molecular, and patient-reported information, then carries it through analytics and into regulatory submissions. In practice that means a pharmaceutical sponsor, a research site, or a patient advocacy group can stand up a non-interventional or Phase IV study, collect data from electronic medical records, wearables, biospecimens, and patient apps, and end up with evidence that is audit-ready by design rather than cleaned up after the fact.
What makes that pitch credible is where the technology has already been used. Embleema's genomic and bioinformatics analytics have run inside U.S. Food and Drug Administration regulatory review environments - a rare validation for a company this small - and the platform underpins studies including the Lupus Landmark Study and the Human Epilepsy Project.
Who uses it. Embleema's customers are pharmaceutical and biotech sponsors, clinical research sites and care centers, and patient advocacy communities - the organizations that need clean, longitudinal, real-world data to study how treatments perform outside a controlled trial. The Lupus Landmark Study, described as the largest lupus study in the world, and the Human Epilepsy Project are among the programs that have run on the platform.
The problem it solves. Traditional studies bleed time and money into custom software, manual data entry, and CRO coordination. Data arrives late, in incompatible formats, without a clear provenance trail - which is exactly what regulators scrutinize. Embleema attacks the collection layer first.
What changes. The company reports that its approach can cut clinical research costs by roughly 40% and save clinicians about two hours per patient per visit by removing double data entry. Studies can be configured without custom code, which widens who can actually run one.
The bet. Fix data quality at the source - source-tracked fields, dynamic consent, harmonized formats - and the evidence is trustworthy from day one instead of being reconstructed later. That is the difference between a dataset and a submission.
“Embleema is the only end-to-end data platform for personalized medicine unifying clinical, real-world, molecular data, analytics and regulatory submissions.”
The core product: multimodal real-world data aggregation from patient apps, sites, EMRs, wearables, genomics, and biospecimens, with no-code drag-and-drop protocol configuration, source-tracked audit-ready capture, and dynamic consent for non-interventional and Phase IV studies.
Embleema's original blockchain-based personal health record. It let patients assemble their health history from dispersed records and devices like Fitbit, control sharing through smart contracts, and take part in research - the data-ownership thesis the company was born on.
A genomic and biomarker analytics capability associated with FDA regulatory review environments, and connected to standards work for cell and gene therapies. This is the piece that made "regulatory-grade" more than a slogan.
Dynamic consent management plus patient-facing engagement - real-time nudges and personalized health insights - integrating 60,000+ care centers and 550+ wearable devices into one longitudinal record.
Real-world evidence has become one of the busier corners of health-tech, with players like Aetion, TriNetX, Verana Health, Datavant, Komodo Health, Medable, and the incumbents Medidata and IQVIA all staking claims. Many of them start from analytics - building dashboards and models on top of data that already exists, warts and all.
Embleema's differentiation is that it starts one step earlier, at collection. By making data source-tracked, consented, and harmonized as it comes in, the company aims to produce evidence that is regulatory-grade from the start rather than scrubbed into shape afterward. Its FDA usage and its origins in patient-owned records give it a provenance-and-trust story that is harder to retrofit.
The company sits at the intersection of real-world data, decentralized clinical trials, and precision medicine - three trends that have all moved toward it since it was founded in 2017. Being early to decentralized studies looked eccentric before the pandemic normalized them; today the market has walked in Embleema's direction.
Robert Chu, Co-Founder & CEO. Chu left his role as Senior Vice President of Global Technology Solutions at IMS Health (now IQVIA) - where he had built and managed data networks across more than 20 countries - to start Embleema in June 2017. He co-founded the company with Nicolas Schmidt, its Chief Product Officer. The leadership bench draws from Harvard Medical School, Pierre Fabre, T-Systems, and Nokia/Withings.
Business model. Embleema is B2B SaaS. It licenses its platform to sponsors, research sites, and patient groups, earning revenue through subscriptions and study-based data services. The value proposition is faster study startup, less manual data entry, and reduced reliance on custom coding and CROs - a lean, roughly 29-person team supporting dozens of studies.
Robert Chu leaves IMS Health/IQVIA to start Embleema as a patient-driven healthcare blockchain network.
The first blockchain-based personal health record launches in the US, letting patients assemble and control their health data.
Pharmagest acquires ~15% and leads a $3.7M Series A; Embleema joins the Techstars Alchemist Blockchain Accelerator.
Embleema expands from records into a unified real-world data and evidence platform for research and regulatory submissions.
The platform underpins the Lupus Landmark Study and the Human Epilepsy Project and supports FDA genomic regulatory review.
Video links point to publicly searchable interviews and Embleema's own overview video; specific URLs may change over time.
Sources include Business Wire, BioSpace, HIT Consultant, Healthcare Digital, The Silicon Review, GlobeNewswire, pharmaphorum, Healthcare Weekly, and Embleema's own site. Figures are drawn from public press releases and may be approximate.