The Integration Audit
You can buy SOPs. You can buy software. You can hire a CRO. But compliance doesn’t fail at the documents or the software — it fails at the seams between them. This 8-question diagnostic surfaces the seams piecemeal can’t cover.
Who owns the gap between your CRO’s monitoring plan and your sponsor QTL thresholds?
If a KRI breaches tomorrow, is there a written, tested escalation path from breach to corrective action?
Can you trace any submitted data point back to its source in under 30 minutes?
Is your EDC audit trail review defined in an SOP and actually executed every cycle?
Who reconciles your CRO’s TMF index against your sponsor TMF before inspection?
Do your vendor agreements assign data governance responsibilities under Annex 1, including trial-specific Annex 2 considerations where applicable?
When was your protocol template last updated for ICH E6(R3) Appendix B?
If an inspector asked “show me your quality tolerance limits” tomorrow, could you?
0 of 8 answered
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Compliance & Transparency
oPoS is an advisory decision-support tool designed to assist clinical trial planning. It does not replace professional regulatory judgment. The methodology is designed to support ICH E6(R3)-aligned assessment, sponsor oversight documentation, and decision evidence. The platform may process business contact information, uploaded protocol materials, and other user-provided content. Do not upload PHI unless appropriate agreements and safeguards are in place. VeriAbyss™ provides AI-assisted consistency review; outputs remain advisory until qualified human review.
© 2026 BleuConsult. All methodologies, frameworks, assessment logic, and library materials are the proprietary intellectual property of BleuConsult. All rights reserved.
All assessments are for informational purposes only.
