Inspection-Ready By Design
Compliance is built into how Korio operates, not bolted on afterward. Every study runs inside a structured Quality Management System (QMS), governed by SOPs and designed to protect trial integrity from kickoff through closeout.
You get audit-ready delivery without the administrative burden.
Regulatory Alignment
Korio's QMS supports regulated clinical trials and aligns with the expectations sponsors and inspectors bring to the table. Every activity is governed, documented, and inspection-ready across the study lifecycle, so your team stays focused on execution.
ICH E6(R3) Guideline for GCP
21 CFR Part 11
EU Annex 11
GAMP 5 risk-based principles
GDPR and data privacy laws
Validation & Controlled Change
Study-specific requirements are defined before setup begins. That upfront clarity aligns teams early, reduces UAT risk, and gets protocol-specific needs into the design from the start. After go-live, every change follows a governed process:
Impact Assessment
Validated Update
Sponsor Approval
Controlled Release
Each change is traceable — and the operational burden of change control stays with Korio, not you.
Security, Data Integrity & Blinding Controls
Study integrity is enforced at the system level across the full lifecycle. Every critical action is attributable and traceable, aligned with ALCOA+ principles. When documentation is needed, it's already structured, available, and inspection-ready.
- Role-based access with blinded and unblinded data kept separate
- Time-stamped audit trails with real-time visibility
- Controlled randomization list handling and emergency unblinding
- Secure hosting, backup, disaster recovery, and business continuity
- Routine security scanning, penetration testing, and monitoring
Controlled. Predictable. Inspection-ready.
With Korio you get inspection-ready delivery, controlled and auditable change, and a system built to your protocol — without the administrative load landing on your team.