Trust & Compliance

Security, privacy and validation, built into the platform

From regulatory compliance and data protection to responsible AI governance, EClinCloud maintains a trust framework across products and delivery. Detailed security architecture and validation documents are available during evaluation under NDA.

Trust framework

Every layer works together to protect clinical evidence

Trusted clinical evidenceBuilt from every interaction
01
Access & identityPrecise authorization · segregation · user verification
02
Validated workflowsControlled configuration · change management · human review
03
Data & auditIntegrity · traceability · backup & protection
04
Quality & governanceSOPs · regulatory frameworks · responsible AI

Regulated trial compliance

Validated for regulated clinical trial use

21 CFR Part 11EU Annex 11ICH E6(R3)GAMP 5CDISCChina GCP (2026)

Security & privacy

Meets cross-border privacy and data protection requirements

ISO 27001ISO 27701GDPRHIPAACSA STAR cloud certification

Quality & operational governance

Traceable end-to-end, controllable in operation

Quality management frameworkChange management controlsBackup & protection mechanismsAudit-ready processesSponsor qualification & audit support

AI governance & trust

The world's first international AI management standard

ISO/IEC 42001:2023 AI Management System certificationHuman review of AI outputsResponsible AI governance framework

Certifications

Certifications as published in current company materials; certificate details available on request.

ISO 27001
ISO 27001
Information security
ISO 9001
ISO 9001
Quality management
ISO 20000
ISO 20000
IT service management
DJCP (China MLPS)
DJCP (China MLPS)
Multi-level protection scheme

Documents available on request

  • Security architecture & data handling
  • System validation & quality documentation
  • Business continuity & backup
  • Access model & audit trail
  • Regional deployment & data residency options

Responsible AI

AI on the ECC platform is always tied to specific tasks — protocol parsing, OCR entry, document classification, risk scanning and Q&A — with humans reviewing outputs. EClinCloud is certified against ISO/IEC 42001:2023, the world's first international standard for AI management systems.

Contact us for materials

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