Clinical Compliance & Regulatory Integrity

Compliance Overview

The Aevum Zenth Clinical Compliance Division operates under a unified Quality Management System (QMS) aligned with ISO 14155:2020 and ICH E6(R3) guidelines. All clinical operations are subject to continuous monitoring, risk-based quality management (RBQM), and independent ethics review.

Regulatory Frameworks & Standards

Governance & Oversight Structure

Compliance authority is distributed across independent committees with direct reporting lines to the Board of Directors.

• Chief Compliance Officer (CCO): Oversees global regulatory strategy, policy enforcement, and cross-divisional alignment.
• Clinical Ethics Review Board (CERB): Independent institutional review board conducting protocol approvals, risk-benefit assessments, and ongoing study oversight.
• Data Safety Monitoring Board (DSMB): External expert panel monitoring trial safety, efficacy, and stopping boundaries for all Phase II/III studies.
• Quality Assurance (QA): Executes routine inspections, CAPA tracking, and vendor/sponsor audits.
• Regulatory Affairs: Manages IND/CTA submissions, variation tracking, and post-market surveillance reporting.

Protocol & Deviation Management

All clinical protocols undergo mandatory version control, medical writer review, and CERB approval prior to initiation. Deviations are classified by risk severity and tracked through our electronic Trial Master File (eTMF).

Data Integrity & Privacy Controls

Clinical data management follows ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available). All electronic systems undergo 21 CFR Part 11 validation including audit trails, electronic signatures, and role-based access controls.

Audit & Inspection Readiness

Aevum Zenth maintains continuous inspection readiness through mock audits, document readiness reviews, and cross-training of site personnel. All audit findings are tracked to closure via our CAPA management system.

• Quarterly internal mock inspections aligned with FDA/EMA inspection guides
• Biannual vendor/sponsor quality assessments
• Real-time eTMF health monitoring (TMFRA scoring ≥ 95%)
• Regulatory correspondence tracking with escalation workflows

Mandatory Training & Certification

All clinical staff, investigators, and contracted personnel must complete role-specific compliance training prior to study activation. Annual recertification is enforced.

Training records are maintained in the LMS and verified during site initiation visits.

Compliance Reporting & Whistleblower Channel

Employees, investigators, and partners are encouraged to report potential compliance violations, ethical concerns, or safety issues through secure, confidential channels. All reports are investigated independently within 10 business days.