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Compliance

The Compliance Ecosystem

To ensure total transparency, we categorize our security and compliance standards into three core pillars:

I. Infrastructure & Security

ISO 27001
We maintain a certified Information Security Management System (ISMS), ensuring that risk management is embedded into every operational process.
SOC 2 Type II
Our controls for security, availability, and processing integrity have been independently audited and verified over time, providing you with documented assurance of our platform’s reliability.
SOC 3
A public-facing report detailing our security posture, available for your immediate review.
HITRUST CSF
We leverage the HITRUST framework to map complex global security requirements into a single, scalable assessment, demonstrating our advanced maturity.

II. Clinical Standards & Interoperability

UMC Certified Developer
As a formally vetted developer, our platform’s integration with the WHO Drug Dictionary is independently verified by the Uppsala Monitoring Centre. This guarantees high-fidelity drug coding and pharmacovigilance data mapping, reducing manual errors and accelerating your regulatory timelines.
21 CFR Part 11
Our platform is engineered to comply with FDA requirements for electronic records and signatures, featuring immutable audit trails and granular, role-based data access.
FDA Data Standards Alignment
We strictly adhere to industry-standard terminology, including MedDRA and WHODrug, ensuring your data is always submission-ready.

III. Global Privacy & Regulatory Reach

HIPAA
We enforce rigorous technical and administrative safeguards to ensure the confidentiality and integrity of Protected Health Information (PHI).
GDPR
Our platform is architected to respect data sovereignty, facilitating compliant clinical research across European borders.
DSP 14117 & HGRAC
We provide the necessary technical controls and oversight for the secure, legal transfer and management of sensitive human genetic resources and bulk data in international trials.

Commitment to Governance

Beyond our certifications, we align our platform architecture with ICH E6(R2) principles, emphasizing risk-based monitoring and data quality oversight. If you require a custom audit or have specific security questionnaire requirements, please reach out directly to our security governance team.
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