generated: '2026-09-05'
method: searched
probe: true
source: https://www.4gclinical.com/trust-center
url: https://www.4gclinical.com/trust-center
name: 4G Clinical Trust Center
sections:
- Security and Quality
- Quality System
- Insights and Publications
- Data Privacy
- Sustainability
- FAQs
certifications:
- id: soc2-type2
  name: SOC 2 Type 2
  criteria: [Security, Availability, Confidentiality]
  period: 12-month period ending 2025-08-31
  auditor: certified public accounting firm (not named on the page)
  report_available: on request via the Security and Quality contact form
- id: dpf
  name: EU-US Data Privacy Framework (incl. UK Extension and Swiss-US DPF)
  status: active participant, certified with the U.S. Department of Commerce
- id: ecovadis
  name: EcoVadis
  status: Committed Badge, assessment completed 2025-08
- id: un-global-compact
  name: United Nations Global Compact
  status: participant / signatory support
regulatory_frameworks:
- id: 21-cfr-part-11
  name: 21 CFR Part 11 — Electronic Records and Electronic Signatures
  claim: compliance maintained through the Quality Management System
- id: eu-annex-11
  name: EudraLex Volume 4 Annex 11 — Computerised Systems
  claim: compliance maintained through the Quality Management System
- id: gdpr
  name: GDPR (EU) 2016/679
  claim: compliant as a data processor; Article 27 representative not required (EU establishment
    in the Netherlands)
- id: ccpa
  name: California Consumer Privacy Act (as amended)
  claim: compliant
- id: alcoa-plus-plus
  name: ALCOA++ data integrity principles
  claim: adhered to via QMS controls, audit trails and access management
quality_system:
  capa: documented Corrective and Preventive Action process, severity-categorised and tracked
    to closure
  audit_trail: 60+ audit tables capturing user, timestamp, and old/new values; human-readable
    reports for inspection
  validation: validation plans, requirements, test scripts, traceability matrices and
    statements of regulatory compliance under change control
  access_control: unique credentials, role-based access control, multi-factor authentication
  reviews: quarterly governance meetings with clients (delivery timelines, UAT defects,
    support resolution, CAPA metrics)
hipaa:
  covered_entity: false
  business_associate: false
  rationale: >-
    4G Clinical states it receives only pseudonymized subject IDs and does not hold the
    information required to re-identify a subject, so it is neither a covered entity nor a
    business associate under HIPAA.
registrations:
- registry: EMA Organisation Management Service (OMS)
  entries:
  - org: 4G Clinical LLC (US)
    id: ORG-100042775
  - org: 4G Clinical B.V. (Netherlands)
    id: ORG-100044721
  url: https://iris.ema.europa.eu/locations/
not_claimed:
- ISO 27001
- ISO 9001
- HITRUST
- FedRAMP
- PCI DSS
- CSA STAR
subprocessors:
  url: https://www.4gclinical.com/subprocessors
  last_updated: '2025-12-10'
  count: 18
  hosting: Amazon Web Services Inc. (USA) and Amazon Web Services EMEA SARL (EU)
evidence:
- source: https://www.4gclinical.com/trust-center
  http_status: 200
  fetched: '2026-09-05'
  keywords: [soc 2 type 2, 21 cfr part 11, annex 11, gdpr, data privacy framework, alcoa++,
    trust center]
- source: https://www.4gclinical.com/subprocessors
  http_status: 200
  fetched: '2026-09-05'