Embleema

Market position

Embleema competes in the real-world evidence and decentralized clinical trial market alongside Aetion, TriNetX, Verana Health, Datavant, Komodo Health, Medable and incumbents Medidata and IQVIA. It is a small company relative to these peers, with roughly 29 employees and Series A funding, and claims adoption by seven in ten top U.S. research institutions. Its FDA usage and patient-owned-record origins are cited as its provenance-and-trust positioning at the intersection of real-world data, decentralized trials and precision medicine.

Embleema positions itself at the data-collection layer rather than the analytics layer that many real-world evidence vendors start from, aiming to make data source-tracked, consented and harmonized at capture so that evidence is regulatory-grade from the outset rather than remediated afterward. Additional differentiators cited include use of its genomic and bioinformatics analytics inside FDA regulatory review environments, a consent system supporting re-consent and granular data-sharing preferences, no-code protocol configuration that removes custom build work, and a single platform spanning patient, site, sponsor and regulatory needs without CRO involvement.

Technology

The platform ingests structured and unstructured data from sites and patients and integrates records from more than 60,000 care centers and over 550 wearable devices. Components include no-code, drag-and-drop protocol configuration, auto-populated eCRFs with built-in validation, AI-powered data entry, real-time longitudinal e-consent with re-consent and granular sharing controls, field-level source tracking for auditability, and normalization, enrichment and bioinformatics analytics for complex modalities including genomic, imaging and spectral data. A blockchain layer underlies the auditable record of consent. The company states the platform was originally developed in collaboration with the FDA and that its genomic analytics capability is associated with FDA regulatory review environments and standards work for cell and gene therapies.

Go-to-market

The company sells directly to pharmaceutical and biotech sponsors, research foundations and academic institutions, with commercial efforts led by an account executive covering pharma, biotech and nonprofit research organizations. Demand generation runs through demo requests, published case studies and marketing campaigns. Patient recruitment operates through partnerships with patient advocacy groups and condition-specific communities, which feed consented patient communities available to sponsors for enrollment and follow-up.

Pharmaceutical and biotech sponsors, clinical research sites and care centers, research foundations, academic institutions and patient advocacy communities running registries, non-interventional and Phase IV studies; patients and advocacy group members participate as data contributors.

Geography

Headquartered in New York, with offices described at 44 West 28th Street in Manhattan, and described as having deep roots in France. Data connectivity covers more than 60,000 care centers drawing EMR data across the United States.

History

Embleema was co-founded in New York by Robert Chu and Nicolas Schmidt, with 2017 given as the founding year in press profiles. It emerged from stealth in 2018 with PatientTruth, a blockchain-based personal health record through which patients could assemble records from dispersed sources and devices such as Fitbit, control sharing via smart contracts and participate in research. A Series A round closed in 2019, and Pharmagest acquired an approximately 15% stake in January 2019. The company subsequently shifted its positioning from blockchain toward clinical operations software, launching its real-world evidence platform in 2019 and emphasizing decentralized and hybrid studies, AI-assisted data handling and no-code protocol configuration. Reported headcount was about 23 in 2024 and about 29 more recently, with reported 2024 revenue of approximately $3.1 million.

Risks & controversies

The company's initial market positioning relied on blockchain messaging that later fell out of fashion, requiring a repositioning toward clinical operations software, and press coverage notes an open question as to whether its patient-centric thesis is what closes pharmaceutical deals. It remains a small organization — roughly 29 employees and about $4 million raised — competing against substantially larger incumbents such as Medidata and IQVIA. Several performance figures, including cost reduction, completeness and institutional adoption rates, are company-reported.