What Is Different
Not another CRO.
We built DEOX from the sponsor side of the table. Fewer layers, sharper execution, and a team that actually pays attention to your programme.
Every decision from your side
MHRA + HRA
or pass-through fees
workflow
Lean operating model
No PMs, no CTLs, no CRM bloat. Just the leadership team, people on the ground, and outsourced experts where needed. Two layers between you and delivery.
Capital-efficient delivery
Your budget goes into the people actually running your study, not executive layers soaking it up. Transparent, milestone-aligned, and respectful of your runway. Full GxP delivery at a fraction of traditional CRO costs.
AI-native operations
AI threads through every function — study start-up, regulatory intelligence, TMF indexing, query management, and day-to-day QMS compliance monitoring. It handles the document-heavy, process-driven work so your team can focus on decisions that matter.
Expert network, not a bench
We don't need every role sat in our office. We know how to engage the right experts, secure good deals, and we know what good looks like. Functional specialists brought in as your study needs them — no bench overhead, no wasted layers, no compromise on quality.
UK regulatory depth
Very clued up on UK SI 2004/1031, MHRA, HRA, and the post-Brexit landscape. AI continuously pulls regulatory updates and feeds them into our QMS so it stays current automatically. Connected to the NHS through our CMO. We run studies — this isn't theoretical.
Quality by Design
Quality isn't an audit step at the end — it's built into the foundation from day one. SOPs, process maps, policies, AI-powered compliance monitoring, and real-time deviation detection. Inspection-ready at every stage, not just before the inspector arrives.
What we actually deliver
Study Start-Up
From protocol development through to first patient in. We manage the full regulatory pathway: MHRA Clinical Trial Authorisation via the Combined Review, HRA Ethics Committee submission through IRAS, and NHS site-level R&D approvals.
- Protocol and SAP development
- Investigator brochure compilation
- CTA submission and regulatory liaison
- Site feasibility, selection, and activation
- EC and R&D submissions (IRAS pathway)
- Investigator meeting coordination
- ISF/ICF development and translation
Clinical Monitoring
Risk-based monitoring strategy designed around your protocol's critical data points. We do not send bodies to sites — we send monitors who understand what matters in your data.
- Risk-based monitoring plans per ICH E6(R2)
- SDV and SDR with targeted source review
- Centralised statistical monitoring
- Site qualification, initiation, and close-out visits
- Ongoing site performance metrics and escalation
- Remote and on-site monitoring capability
Data Management
End-to-end clinical data management with AI-assisted edit checks, query generation, and data review. Designed for clean, inspection-ready datasets that lock on schedule.
- CRF/eCRF design and annotation
- EDC build, validation, and UAT
- Edit check specification and programming
- Medical coding (MedDRA, WHODrug)
- Query management and resolution tracking
- Database lock and data transfer
- AI-assisted data cleaning and anomaly detection
Biostatistics & SAS Programming
Statistical design and analysis through our specialist network. From sample size justification to CSR tables, listings, and figures — we engage experienced biostatisticians who know your therapeutic area.
- Sample size and power calculations
- Randomisation and IWRS specification
- Statistical Analysis Plan development
- Interim and final analyses
- CDISC SDTM and ADaM datasets
- CSR statistical outputs (TLFs)
Regulatory & TMF Management
Your Trial Master File is inspection-ready at all times — not assembled retrospectively when the inspector calls. We follow the TMF Reference Model and use AI-powered indexing to keep everything current.
- eTMF setup, population, and QC
- TMF Reference Model compliance
- Regulatory submission management (MHRA, HRA)
- Annual progress reports and safety updates
- Substantial and non-substantial amendments
- End-of-trial notifications and clinical study reports
Quality Management
A QMS designed for the real world — not a bureaucratic exercise. Inspection-ready documentation, AI-powered compliance monitoring, and deviation management that actually prevents recurrence.
- QMS design, implementation, and maintenance
- SOP authoring, review, and version control
- Deviation and CAPA management
- Internal audits and inspection preparation
- Training programme design and documentation
- Vendor qualification and oversight
- AI compliance monitoring and deviation detection
Pharmacovigilance
Safety reporting that meets regulatory timelines without fail. Our PV specialists handle SUSAR reporting, DSUR compilation, and signal detection through established expert partnerships.
- SUSAR expedited reporting (MHRA, EMA)
- DSUR/PSUR compilation
- Safety database management
- Signal detection and benefit-risk assessment
- DSMB coordination and meeting support
- Reference safety information management
Clinical Supply & Logistics
Coordinating IMP manufacture, labelling, distribution, and accountability across your UK site network. We manage the supply chain so you do not have to worry about site stockouts or temperature excursions.
- IMP depot and distribution coordination
- Labelling and packaging specification
- Temperature chain management and monitoring
- Site-level accountability and reconciliation
- IWRS/IRT specification and management
- Return and destruction documentation
See the difference for yourself
Let's talk about your programme and show you what sponsor-sided delivery actually looks like.
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