Data integrity & compliance, by design
ECS® places security and compliance at the core of its infrastructure. Every user interaction is tracked via audit trails, while role-based permissions and encryption ensure maximum protection of sensitive data. Researchers, sponsors and regulators can trace how every study result came to be, and who touched it.
Engineered from the ground up
ECS® meets stringent regulatory expectations, embedding compliance into every layer of the system architecture and aligned with recognised cybersecurity guidance (ISO 27001, NIST, OWASP).
Records & signatures
21 CFR Part 11, EU Annex 11 and GAMP 5: electronic records and signatures as reliable as their paper equivalents, with a GxP-grade audit trail on every interaction.
Good Clinical Practice
ICH E6(R3) and E8(R1) quality-by-design embedded from protocol to data lock, extended to GVP for vigilance and safety reporting.
Privacy & consent
GDPR and HIPAA readiness: data minimisation, lawful-basis controls and granular, revocable consent scoped across every module.
Security architecture
Engineered against ISO 27001, NIST and OWASP. Role-based access, encryption at rest and in transit, continuous monitoring, regional data residency in the sponsor's jurisdiction.
Device-enabled studies
MDR / IVDR and ISO 14155: connected hardware treated per class, with declarations and conformity evidence kept in the eTMF.
Interoperability & AI governance
HL7 FHIR and CDISC SDTM / ADaM for exchange and analysis. Where AI interprets study signals, EU AI Act transparency, explainability and human oversight apply by design.
Governance choices that go past the checklist.
Three architectural commitments.
EU-standard metadata
HealthDCAT-AP conformant and SHACL validated, aligned with EU health-data metadata standards.
Three consent levels
Granular, revocable consent, including delegated / proxy consent for minors, dependents and care-partner scenarios, configured per study.
Compute-to-data
Analysis runs where the data lives. Answers travel, records don't, privacy by architecture.
Plays well with your systems
HL7 FHIR, HL7 v2 and REST APIs for EHR ingestion, lab result import and downstream integration. CDISC SDTM / ADaM-ready exports for statistical analysis. Multi-tenant, multi-region cloud with data-residency options.
Trace every result, from capture to report.
Every action is dated, attributed and documented. We'll show you how the data trail works.