Trust, Security & Compliance

Built for Regulated Clinical Research

CliniQR is designed to support the privacy, security, and regulatory obligations of Contract Research Organizations, research sites, and sponsors—without increasing operational burden or centralizing sensitive patient data.

Trust and compliance illustration

Security by Design

CliniQR was architected specifically for clinical research environments where data integrity, auditability, and patient trust are critical.

PHI Minimization

CliniQR does not store patient health records or clinical results. Tokenized events and consent metadata are used to enable secure workflows while reducing exposure risk.

Event‑Based Tokenization

Unique, immutable tokens represent patient consent and interaction events, supporting traceability without centralizing identifiable health data.

Wraparound Architecture

CliniQR integrates around existing site and CRO systems, allowing organizations to maintain their established governance and standard operating procedures.

Regulatory Alignment

Designed to support compliance obligations across U.S. and global clinical research programs.

HIPAA‑Aligned

Encryption in transit and at rest, PHI minimization, and role‑based access principles.

21 CFR Part 11 Support

Electronic records and signatures support, audit trails, and event traceability.

2FA SMS Authentication

Secure patient authentication for consent and messaging workflows.

Decentralized Trials Ready

Supports hybrid and decentralized clinical trials without introducing new data silos.

Data Governance & Control

CliniQR is intentionally designed to respect the boundaries between patients, sites, CROs, and sponsors.

  • Sites and providers retain control over clinical data
  • No requirement to replace EHR, CTMS, or site systems
  • Consent and interaction events are auditable and traceable
  • Supports existing IRB, QA, and monitoring processes
Clinical data governance flow diagram

Audit & Due‑Diligence Ready

CliniQR supports CRO and sponsor audit expectations by providing clear documentation and transparent system behavior.

Security Overview

Architecture, encryption, and access controls

Compliance Mapping

HIPAA and 21 CFR Part 11 alignment documentation

Workflow Documentation

Patient journey, consent, and event handling

Need Compliance or Security Details?

Our team can provide documentation to support CRO, sponsor, and site security reviews.

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