Compliance
Compliance
Compliance
Global research standards, natively met
Global research standards, natively met
Embleema complies with HIPAA, GDPR, ICH E6(R2) Good Clinical Practice, and local privacy laws, and is 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 privacy laws, and is 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 privacy laws, and is used by the FDA, DoD, and leading research organizations in the US, Canada, and Europe.
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
Powering innovation across federal health initiatives
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.
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.
Powering innovation across federal health initiatives
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.
Data security audits for all major research sites
Data security audits for all major research sites
Proven, audited, and deployed at scale
We deliver secure, compliant deployments trusted by Mayo Clinic, Johns Hopkins, and NYU Langone, meeting 30+ data security and privacy standards across 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
Proven, audited, and deployed at scale
We deliver secure, compliant deployments trusted by Mayo Clinic, Johns Hopkins, and NYU Langone, meeting 30+ data security and privacy standards across 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
Data security audits for all major research sites
Proven, audited, and deployed at scale
We deliver secure, compliant deployments trusted by Mayo Clinic, Johns Hopkins, and NYU Langone, meeting 30+ data security and privacy standards across 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
Developed for patient-centric privacy
Developed for patient-centric privacy
Unlike traditional RWD aggregators, our consent-first model ensures patient-authorized data, exceeds HIPAA and GDPR standards, and supports trusted sharing for all 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
Unlike traditional RWD aggregators, our consent-first model ensures patient-authorized data, exceeds HIPAA and GDPR standards, and supports trusted sharing for all 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
Developed for patient-centric privacy
Unlike traditional RWD aggregators, our consent-first model ensures patient-authorized data, exceeds HIPAA and GDPR standards, and supports trusted sharing for all 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
Compliance peace of mind, by design
Learn more about our mission critical deployments at the FDA, DoD and major research institutions.
Compliance peace of mind, by design
Learn more about our mission critical deployments at the FDA, DoD and major research institutions.
Compliance peace of mind, by design
Learn more about our mission critical deployments at the FDA, DoD and major research institutions.