Compliance

Compliance

Compliance

Global research
standards,
natively met

Global research standards, natively met

Global research standards, natively met

Embleema complies with HIPAA, GDPR, ICH E6(R2) Good Clinical Practice, and local data privacy laws. Our platform is vetted and used by the FDA, DoD, and leading research organizations in the US, Canada, and Europe.

Embleema complies with HIPAA, GDPR, ICH E6(R2) Good Clinical Practice, and local data privacy laws. Our platform is vetted and used by the FDA, DoD, and leading research organizations in the US, Canada, and Europe.

Embleema complies with HIPAA, GDPR, ICH E6(R2) Good Clinical Practice, and local data privacy laws. Our platform is vetted and used by the FDA, DoD, and leading research organizations in the US, Canada, and Europe.

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Our Clients

Depth in standards, breadth in reach

HIPAA & GDPR compliant

Secure, privacy-first infrastructure that meets U.S. and international data protection requirements.

Federal agency implementations

Compliant with FISMA Moderate requirements, meeting NIST-800 standards, with FDA Authorization to Operate (ATO).

ICH E6 aligned

Built-in audit trails, end-to-end provenance and 21 CFR Part 11–compliant e-signatures ensure clinical data management and integrity in line with ICH E6.

Enterprise-grade security

We follow ISO 27001 practices and leverage SOC 2-compliant cloud infrastructure to uphold data integrity, security, and trust across every study.

Confidence in every submission

Powering innovation across federal health initiatives

Onboard in days, engage them for years—patients thrive as research partners.

Used by the DoD, FDA, and NIH to support mission- critical research.

Our platform is used by the FDA for its regulatory evaluation of cutting-edge precision medicine health products and the DoD for analyzing complex genomic data.

Real-time nudges, personalized insights, and shareable health reports motivate participants to keep logging and actively sharing data, maintaining strong engagement.

Onboard in days, engage them for years—patients thrive as research partners.

Real-time nudges, personalized insights, and shareable health reports motivate participants to keep logging and actively sharing data, maintaining strong engagement.

Data security audits for all major research sites

Skip the custom and labor-intensive build bill

Proven, audited, and deployed at scale

We deliver secure, compliant deployments trusted by top research institutions like Mayo Clinic, Johns Hopkins, and NYU Langone, meeting over 30 data security and privacy provisions in the US, Canada, and Europe.

  • Audited by leading research sites

  • Powers 100+ regulatory submissions at the FDA

  • Trusted for compliant, large-scale clinical studies and registries

Ditch the patchwork of solutions—launch fast with modular tools, full-service design, flexible hybrid or siteless setup, clinical-grade data, sustained retention, and audit-ready outputs, all without extra coding or CRO lift.

Skip the custom and labor-intensive build bill

Ditch the patchwork of solutions—launch fast with modular tools, full-service design, flexible hybrid or siteless setup, clinical-grade data, sustained retention, and audit-ready outputs, all without extra coding or CRO lift.

Developed for patient-centric privacy

Onboard in days, engage them for years—patients thrive as research partners.

Patients are partners, not subjects

Unlike traditional RWD aggregators, our consent‑first model ensures all data is patient‑authorized, exceeds HIPAA and GDPR standards, and enables trusted data and biospecimen sharing for current, future, and secondary studies.

  • Enables ongoing, flexible consent for real‑world studies

  • Exceeds global privacy standards (HIPAA, GDPR)

  • Gives sponsors and biobanks real‑time consent status for data and specimens

Real-time nudges, personalized insights, and shareable health reports motivate participants to keep logging and actively sharing data, maintaining strong engagement.

Onboard in days, engage them for years—patients thrive as research partners.

Real-time nudges, personalized insights, and shareable health reports motivate participants to keep logging and actively sharing data, maintaining strong engagement.

Read about our work in the news

Read our scientific publications

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Compliance peace of mind, by design

Learn more about our mission critical deployments at the FDA, DoD and major research institutions.

Request a demo

Compliance peace of mind, by design

Learn more about our mission critical deployments at the FDA, DoD and major research institutions.

Request a demo

Compliance peace of mind, by design

Learn more about our mission critical deployments at the FDA, DoD and major research institutions.

Request a demo