Embleema
Embleema builds the HIVE real-world data platform that unifies EHR, wearable, genomic, biospecimen, and patient-reported data into regulatory-grade datasets for Phase IV and non-interventional research, serving pharmaceutical sponsors, academic research sites, and patient advocacy organizations.
- Company typePrivate
- Founded2017
- HeadquartersNew York, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Embleema does
Embleema Inc. is a U.S.-based, privately held clinical data platform company founded in 2017 and headquartered in Metuchen, New Jersey (Delaware corporation). It builds the HIVE (High-Performance Integrated Virtual Environment) platform, a no-code, multimodal real-world data system designed for Phase IV and non-interventional research. The platform unifies electronic medical record data from 60,000+ care centers, 550+ wearables, genomic and biospecimen sources, and patient-reported outcomes into regulatory-grade datasets, with dynamic consent management, 21 CFR Part 11 audit trails, and CDISC-compliant outputs. Modular products include the core Embleema Platform, a Patient App, a Site Coordinator EDC, Dynamic Consent Management, Biospecimen Intelligence (built with Astoriom), the HIVE bioinformatics layer, and condition-specific communities such as the BET epilepsy registry co-developed with the Epilepsy Foundation.
The company serves three primary customer segments: pharmaceutical and biotech sponsors (e.g., Eisai, Galderma) seeking CRO-displacing RWE and registry infrastructure; academic research sites and investigators (Mayo Clinic, Johns Hopkins, NYU Langone) running multi-site registries; and patient advocacy organizations and patients (Lupus Research Alliance, Epilepsy Foundation, Epilepsy Study Consortium). Federal agencies (FDA, DoD, NIH) also use the platform for bioinformatics and regulatory analysis. Embleema operates a direct enterprise field-sales motion complemented by patient-community-led growth and event-driven demand generation (SCOPE, SCOPE Europe).
Embleema generates revenue primarily through a fixed-fee, multi-year subscription model for platform access, with module-based pricing and one-time study setup services. The model is positioned as 40% cheaper than traditional CRO approaches and targets cost overruns and long timelines in registry and real-world evidence programs. Pricing is not publicly disclosed. As of 2025, the company had raised approximately $3.7M in seed funding (Pharmagest, Techstars, 2019) with no subsequent priced round disclosed, employs 11-50 people, and reports penetration across 7 of the top 10 U.S. research institutions, with 100+ regulatory submissions supported at the FDA.
Embleema firmographics
Firmographics- Name
- Embleema
- Legal name
- Embleema Inc.
- Website
- https://embleema.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Embleema builds the HIVE real-world data platform that unifies EHR, wearable, genomic, biospecimen, and patient-reported data into regulatory-grade datasets for Phase IV and non-interventional research, serving pharmaceutical sponsors, academic research sites, and patient advocacy organizations.
- Ownership category
- akta.pro rank
Embleema industry classification
Industry- Product category
- Clinical Research Technology / Real-World Evidence Platform
- NAICS
- Software Publishers (5132), Computer Systems Design and Related Services (54151), Custom Computer Programming Services (541511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Prepackaged Software (7372), Services-Computer Programming, Data Processing, Etc. (7370), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Electronic Data Capture (EDC) Platforms (HLACAOAA)
- akta.pro secondary industries
- eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB), Clinical Forms, Templates & Digital Consent (eSignature) (HLACAAAJ), Site Data Management Support (EDC/Source/SDV Readiness) (HLAGACAL), Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB)
Keywords
Where Embleema is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Embleema business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- Platform Subscription / Fixed-Fee: Fixed-fee pricing model for platform access and study setup. Sponsors pay for modules they use with predictable budgets from day one. Model positions as lower cost alternative to traditional CRO technology stacks while providing access to full team and platform capabilities.
- Study Setup and Configuration Services: Team sets up each study using flexible no-code platform. One-time setup fees integrated into fixed-fee structure with no hidden costs or upsells.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Fixed-fee platform access with module-based pricing |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels7 records
Embleema product offering
Product offeringCore offering
Embleema sells a unified, no-code multimodal real-world data platform for Phase IV and non-interventional research that captures and integrates EHR, genomic, clinical, biospecimen, wearable, and patient-reported data into regulatory-grade datasets. The platform bundles a Site Coordinator EDC, a Patient App, the HIVE bioinformatics engine, Dynamic Consent Management, and condition-specific patient community modules (e.g., BET for epilepsy) and is licensed primarily to pharmaceutical sponsors, biotech firms, and academic research centers on a fixed-fee subscription with setup services.
Product overview
Embleema is a unified, multimodal real-world data platform designed for Phase IV and non-interventional research. The core Embleema Platform combines patient and site applications with genomic, clinical, and patient-reported data to deliver multimodal datasets in weeks at 40% lower cost. The architecture includes: the core Platform (configurable no-code EDC with EHR integration from 60,000+ care centers), Patient App (for symptom tracking and data sharing), Site Coordinator Platform (EDC with EMR pre-fills and quality controls), Dynamic Consent Management (standalone consent governance layer), Biospecimen Intelligence (specimen-consent-data unification), the HIVE bioinformatics platform (regulatory analytics), and the BET epilepsy registry app. Additional modules include the Patient Community Network for recruitment and the Integrated Specimen Management Suite (powered by Embleema and Astoriom).
Differentiator
Problem solved
Functional benefit
Products and services
- Embleema Platform (Core Multimodal Real-World Data Platform) Unified, no-code multimodal real-world data platform for Phase IV and non-interventional research that captures and integrates EHR, genomic, clinical, biospecimen, wearable, and patient-reported data into regulatory-grade datasets; sold to pharmaceutical sponsors, biotech firms, and academic research centers on a fixed-fee subscription with study-setup services.
- Patient App Mobile-first patient application enabling symptom tracking, seizure logging, medication monitoring, wearable data sync, and EHR connection; returns data to patients and delivers personalized services to enhance engagement and adherence for use by patients participating in sponsor-led studies.
- Site Coordinator Platform (EDC) Advanced Electronic Data Capture (EDC) system for research sites with EMR integration, drag-and-drop PDF-to-eCRF conversion, real-time edit checks, and customizable workflows; includes role-based task lists, pre-filled data fields, and integrated quality control tools for academic medical centers and investigator sites.
- HIVE Platform (High-Performance Integrated Virtual Environment) Bioinformatics and regulatory analytics platform that transforms raw data from connected devices, trackers, and medical records into regulatory-grade evidence; ensures data provenance and regulatory compliance for clinical research, regulatory submissions, and use by agencies such as the FDA and DoD.
- BET (Battling Epilepsy Together) Platform Patient-first epilepsy registry and self-management app co-developed with the Epilepsy Foundation and Dr. Jacqueline French; enables seizure logging, EMR integration, medication tracking, and clinical trial recruitment with multilingual, mobile-first design for epilepsy patients and research sponsors.
Quantifiable outcome
- 40% lower cost than traditional Phase IV/non-interventional research approaches
- +7 more outcomes
Companies that use Embleema
Customer profileNamed customers8 records
Segments3 records
Ideal customer profiles3 records
Embleema technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration4 records
AI capability5 records
Feature5 records
Embleema partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and major.
- AstoriomcoreStrategic partnership to provide end-to-end biospecimen management solution. Embleema provides consent management and clinical data platform while Astoriom delivers sample storage and biorepository services. Joint solution addresses biosample reuse challenges with integrated consent tracking and sample lifecycle governance.
- CALYMmajorPartnership to deploy next-generation clinical research solutions for life sciences. CALYM is a nonprofit research consortium focused on lymphoma research. Collaboration enables better data management and patient engagement for lymphoma clinical studies.
- Epilepsy FoundationcoreCo-developed the Battling Epilepsy Together (BET) platform - a patient-first epilepsy registry serving as both a self-management app and research engine. Partnership enables patient recruitment and engagement for epilepsy research initiatives.
- Dr. Jacqueline French / Epilepsy Study ConsortiumcoreCo-development of BET platform with Dr. Jacqueline French, Neurology Professor and Epilepsy Study Consortium President. Dr. French provides clinical expertise and leads the Human Epilepsy Project using the platform.
- FDA (U.S. Food and Drug Administration)corePlatform originally developed in collaboration with FDA. Currently used by FDA for bioinformatics analysis of cell and gene therapies regulatory approvals. Powers mission-critical research for FDA, DoD, and NIH.
- DoD (Department of Defense)coreEmbleema platform used by DoD for analyzing complex genomic data. Supports mission-critical research initiatives for defense health programs.
- NIH (National Institutes of Health)corePlatform trusted by NIH for research initiatives. Part of federal health research ecosystem using Embleema for regulatory-grade data management.
Scale indicators12 records
Recent moves6 records
Expansion highlights6 records
Embleema competitors and assessment
Company assessmentDirect peers
- Veeva Systems: Veeva Vault Clinical and CDB platforms provide EDC, CTMS, and eTMF for life sciences. Competes with Embleema in the unified clinical data platform category, particularly with larger enterprise sponsors that prefer Veeva's broader application suite.
- TriNetX: Real-world evidence network and federated query platform used by pharma sponsors and academic medical centers. Comparable to Embleema in connecting EHR data for observational research and clinical trial feasibility, with a strong footprint in academic medical centers.
- Medidata (Dassault Systèmes): Industry-leading EDC and clinical trial technology platform used by the majority of large pharma sponsors. Directly comparable to Embleema on EDC, eCOA/ePRO, and clinical data management, but at vastly greater scale and with broader protocol coverage.
- Signant Health: Specializes in eCOA, ePRO, and patient-centric clinical outcome assessments — directly overlapping with Embleema's Patient App and ePRO capture capabilities. A meaningful peer for sponsors evaluating patient-reported data capture quality and engagement.
- Clario: Generates clinical evidence via eCOA, medical imaging, cardiac safety, and wearables integrations. Comparable to Embleema on wearable data capture and multimodal evidence generation, with stronger scale in cardiac and imaging endpoints.
- Oracle Clinical One: Oracle's unified clinical trial platform (acquired from Phase Forward and goBalto) competes head-on with Embleema in EDC, RTSM, and clinical data management for pharma and CROs, with deep integration into Oracle's broader health and analytics stack.
Broad incumbents
- IQVIA: Largest CRO and clinical data analytics incumbent — and notably the former employer of Embleema's CEO. Competes with Embleema across RWE, EDC, and clinical operations services; IQVIA's E360 platform and Orchestrated Customer Engagement overlap directly with Embleema's value proposition.
Emerging players
- Castor: Cloud-based EDC platform focused on decentralized and hybrid clinical trials. Comparable to Embleema on eCRF build speed, integrations, and direct-to-site usability, though with less multimodal/wearables and consent depth.
- Owkin: AI-driven multimodal clinical and omics data platform for pharma research. Comparable to Embleema on multimodal data integration and AI-powered evidence generation, though Owkin focuses more on AI/ML model development than EDC and registries.
- Datavant: Health data connectivity and tokenization layer that links disparate patient datasets for research. Comparable to Embleema in the RWE data-unification layer, though more horizontal and infrastructure-oriented than Embleema's full-stack EDC + registry platform.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Embleema social profiles
Digital presenceEmbleema compliance and trust
Trust signalCompliance7 records
Embleema financial estimates
Financial estimateRevenue estimate
Valuation estimate
Embleema leadership team
Management profileNumber of profiles
Profiles10 records
Embleema funding detail
Funding detailFunding overview
Funding rounds2 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Embleema M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Embleema
What does Embleema do?
Embleema sells a unified, no-code multimodal real-world data platform for Phase IV and non-interventional research that captures and integrates EHR, genomic, clinical, biospecimen, wearable, and patient-reported data into regulatory-grade datasets. The platform bundles a Site Coordinator EDC, a Patient App, the HIVE bioinformatics engine, Dynamic Consent Management, and condition-specific patient community modules (e.g., BET for epilepsy) and is licensed primarily to pharmaceutical sponsors, biotech firms, and academic research centers on a fixed-fee subscription with setup services.
Is Embleema a public or private company?
Embleema is a private company. It is classified as venture growth investor backed and is currently operating.
When was Embleema founded?
Embleema was founded in 2017. It employs 11 to 50 people.
Where is Embleema based?
Embleema is headquartered in New York, United States, in the North America region.
How does Embleema make money?
Two revenue lines are on record. Platform Subscription / Fixed-Fee is the primary driver. The others are study Setup and Configuration Services.
Who are Embleema's main competitors?
Direct peers on record are Veeva Systems, TriNetX, Medidata (Dassault Systèmes), Signant Health, Clario and Oracle Clinical One. IQVIA is listed as a broad incumbent. Emerging players are Castor, Owkin and Datavant.
Does Embleema have an API?
No public API is recorded for Embleema.
What industry is Embleema in?
Embleema's product category is Clinical Research Technology / Real-World Evidence Platform. Its primary akta.pro industry code is HLACAOAA, Electronic Data Capture (EDC) Platforms, with a secondary code of HLACAOAB, eCOA/ePRO/eDiary & Patient-Facing Data Collection. Its NAICS code is 5132 and its SIC code is 7372.