GxP-Cloud is the vendor-agnostic, GxP-compliant Statistical Computing Environment that clinical data professionals trust when off-the-shelf simply is not good enough. We have deployed over 100 SCEs. Maybe two or three were identical.
Every organisation comes with its own tool preferences, team structures, submission requirements, and growth trajectories. The variability we see across deployments tells us one thing clearly: there is no universal SCE. There is only the one that fits your requirements.
At GxP-Cloud, your environment is configured around your needs, not a catalogue default. And because everything is templatised on our end, we can move fast. You get a fully customised SCE at a non-customised price. The mixing and matching of tools happens quickly, without the cost overhead you would expect from a bespoke build.
Clinical data does not stand still. Neither do the tools your statisticians, programmers, and data scientists rely on. Too many organisations find themselves squeezed into environments designed around a vendor's preferences — not their workflows, not their pipelines, not their regulatory obligations. We fix that.
Choose the tools that serve your science best. SAS, Posit, Python, R, Spotfire, JMP — or a combination. Your toolkit, your workflow, our qualified infrastructure.
Start where you are. Expand as your programme grows. A Phase 2 environment looks very different from what you need at Phase 3 or NDA submission — we are built for that evolution.
No proprietary lock-in. No database hostage situations. Your data, your tools, your control. Move in when you are ready and out if you ever need to — cleanly and compliantly.
Compliance is foundational, not an afterthought. Every environment ships with IQ/OQ documentation, formal change control, and an independent QA oversight layer already in place.
We stay ahead of evolving regional requirements — EMA, MHRA, FDA — so you are never caught off-guard when guidance changes or a new inspection territory opens up.
We do not tell you which tools to use. We provide the qualified infrastructure, quality system, and operational support to run them compliantly — whatever your combination looks like.
Start with a focused SCE configured for your Phase 2 requirements. GxP-qualified from day one. Submission-ready from the start.
Scale the environment as your programme grows. Add tools, add data capacity, add users. The qualification framework scales with you.
Submit with confidence. Validated outputs, complete audit trail, and full traceability. Our QA team supports your submission preparation.
Pharmacovigilance, post-market surveillance, label updates, and long-term data archiving — all within the same qualified environment.
We design SCE solutions that map to where you are now and scale to where you are going. Short-term deliverables. Long-term roadmap. One partner who has done this before.
Schedule a meetingValidated Cloud routinely supports both governmental regulatory audits and client-facing audits for service providers. We track what regulatory agencies actually examine during inspections through our dedicated audit portal. We know what they are looking for before they arrive.
That institutional knowledge, built across dozens of audits, travels with you as our partner. When an agency walks in the door, you are not starting from scratch. You are walking in with the infrastructure, documentation, and institutional memory of a team that has been there before.
"That is a material advantage at a moment when nothing can go wrong."
We track what regulatory agencies examine during inspections in real time. That knowledge informs how we build and maintain every environment we manage.
Our Quality team does not hand you documentation and step back. They attend inspections alongside you and defend the environment they built and manage.
IQ/OQ documentation, change records, and audit trails are maintained continuously. Not assembled when an inspection is announced. Always ready.
The experience of supporting dozens of regulatory audits across EMA, MHRA, and FDA-regulated environments travels with you as a GxP-Cloud customer.
We track evolving EMA, MHRA, and FDA guidance and act on it proactively. Your environment stays aligned to current expectations, not last year's.
Regulatory scrutiny of statistical computing environments has increased significantly. The question is no longer whether your SAS or Posit environment is qualified. It is whether the infrastructure underneath it is, and whether you can prove it.
Our institutional knowledge of regulatory expectations for statistical computing environments is built from real audits, real inspections, and real clinical data operations. We know what the inspector will ask because we have been in that room before.
GxP-Cloud provides EU data centres, EU contracting through Validated Cloud BV, and a quality framework built around EMA Annex 11 and MHRA requirements. Your clinical data stays in the EU. Your compliance posture is built for European inspection expectations.
Schedule a 30-minute meeting with our EU team. We will assess your current SCE requirements, discuss your tool preferences, and outline what a fully qualified, vendor-agnostic environment looks like for your programme. No commitment required.