Our Process
From first conversation to database lock. A lean, sponsor-sided clinical development process built on GxP quality, AI-assisted efficiency, and senior-level attention at every stage.
Every clinical programme follows a structured delivery lifecycle. The difference with DEOX is that every stage is managed by experienced professionals using AI-assisted tools to accelerate timelines without cutting corners on quality or compliance.
We do not hand your study to a junior team after the contract is signed. The same senior people who scope your programme deliver it — from start-up through close-out.
Phase 1
We start by understanding your programme goals, therapeutic area, and regulatory landscape. Then we assess feasibility — not with generic templates, but with a tailored analysis of the UK site and investigator landscape for your specific study.
Phase 2
This is where AI-assisted document production delivers its biggest impact. We generate first drafts of regulatory-grade documents in hours, not weeks — with full human review at every stage.
Phase 3
During the active study period, DEOX provides continuous clinical monitoring, data management, and safety oversight — using risk-based monitoring principles to focus resources where they matter most.
Phase 4
Study close-out is where many programmes lose momentum. We maintain the same urgency through database lock, CSR preparation, and regulatory close-out reporting.
Regardless of where your programme sits in the lifecycle, these principles are constant:
We work from your priorities, not a vendor margin. Every decision is filtered through what moves your programme forward.
ICH-GCP compliant, inspection-ready, with a QMS designed to be audited — not just to exist on a shelf.
AI accelerates first drafts, QC checks, and compliance monitoring. Humans make every clinical and regulatory decision.
No account managers, no hand-offs. You work directly with experienced clinical professionals throughout.
Every DEOX programme runs on our managed QMS — not a sponsor-specific patchwork. This means:
The result is a quality system that is not just compliant on paper, but operationally effective — and continuously improving.
Our AI tools operate under a formal governance framework. Enterprise-grade models with Business Associate Agreements, zero data retention policies, and full audit trails. No sponsor data is used for model training. Every AI output is logged, versioned, and reviewed by a qualified human before finalisation. Our AI governance SOP and validation documentation are available for sponsor audit on request.
DEOX uses modern, validated tools to support programme delivery:
The practical impact of the DEOX model is measurable:
Every programme is different, and we tailor the delivery model to fit your therapeutic area, phase, and regulatory requirements. But the structure, quality system, and principles remain consistent.