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Trust & assurance

Transparent controls. Responsible claims.

Clinical technology evaluations require evidence, not badges without context. This page summarizes the controls and assurance posture AIClinTrack can represent today.

Platform safeguards

Controls that support governed clinical work

These capabilities support customer security, validation, and compliance processes. They do not replace sponsor/CRO procedural controls, system validation, or inspection preparation.

Role-based access

Access is assigned around study responsibilities so teams can limit visibility and actions appropriately.

Activity history

Key workflow actions retain traceable history to support oversight, review, and evidence gathering.

Encryption safeguards

The platform uses encryption for data in transit and at rest as part of its cloud security approach.

Tenant isolation

Customer environments are logically separated to support controlled handling of organization and study information.

Backup & recovery

Backup and disaster-recovery practices support service continuity and recoverability planning.

Cloud infrastructure

AIClinTrack is hosted on AWS infrastructure in Singapore; deployment details can be discussed during due diligence.

Regulatory readiness

Built to support a risk-based assurance approach

AIClinTrack uses readiness-oriented language for ICH-GCP, ALCOA+ principles, and applicable 21 CFR Part 11 expectations. Fit, intended use, validation, procedures, and final regulatory decisions remain context-specific customer responsibilities.

Certification status

SOC 2 and ISO 27001 remain roadmap initiatives

AIClinTrack does not claim current SOC 2 or ISO 27001 certification. Available security, architecture, and assurance information can be reviewed under appropriate confidentiality terms during vendor assessment.

Shared responsibility

Trust depends on technology, process, and intended use

AIClinTrack

Platform safeguards, controlled development, service operations, and transparent product documentation.

Customer

Intended-use definition, validation, user governance, procedures, training, and regulatory accountability.

Together

Implementation scope, data flows, responsibilities, risk assessment, change control, and support expectations.

Have a security or validation question?

Share your due-diligence requirements and we will respond with the evidence currently available.