Corporate Compliance Framework
At ZENVIO, we recognize that compliance is the backbone of clinical development. Our operations are governed by a rigorous framework designed to ensure participant safety and the highest fidelity of trial data.
ICH-GCP E6 (R2 / R3)
We strictly adhere to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Our processes are updated to meet both R2 and the emerging R3 standards, ensuring global regulatory acceptance of all data generated through our platform.
Quality Management System
Our comprehensive QMS governs every aspect of our clinical Solutions. From vendor qualification to protocol adherence, our automated quality gates ensure that operational risks are identified and mitigated in real-time.
Audit & Inspection Ready
We maintain a "permanent state of readiness" for regulatory audits. Our digital eTMF and blockchain-inspired audit trails allow for immediate, transparent review by global health authorities at any time.
Data Integrity & ALCOA+
Data integrity is paramount. We follow the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) for all data intake and processing.
Ethics & Participant Safety
Participant safety is our highest priority. We work closely with Institutional Review Boards (IRBs) and Ethics Committees to ensure that all digital interventions and remote monitoring protocols exceed standard ethical requirements. Our AI engines are specifically tuned to monitor for emerging safety signals across trial populations, enabling faster investigator intervention.
HIPAA & GDPR Compliance
ZENVIO employs end-to-end encryption and strict access controls to protect Personal Health Information (PHI). We are fully compliant with the Health Insurance Portability and Accountability Act (HIPAA) in the US and General Data Protection Regulation (GDPR) in Europe and beyond.
© 2026 ZENVIO AI Clinical Solutions. Last updated: March 14, 2026.