Statilyze VSCE
Whether you're racing against clinical timelines or navigating complex compliance requirements, Statilyze by Katalyze Data is your trusted partner — a fully managed, GxP-compliant VSCE designed to fit your needs and scale with your goals.
Statilyze is a fully managed, validated statistical computing environment built for pharmaceutical and clinical organisations. It brings together the tools, governance and infrastructure your biostatistics and data management teams need — in a single, compliant platform you can trust at every stage of the trial lifecycle.
Statilyze is Katalyze Data's validated statistical computing environment — purpose-built for clinical trials and regulatory submissions. It centralises SAS, R and Python tooling inside a fully managed, GxP-compliant platform, replacing fragmented local environments with a governed, version-controlled workspace that satisfies regulatory authorities and supports faster trial reporting.
Pharmaceutical companies, CROs and clinical research organisations that need a compliant, scalable computing environment for biostatistics, data management and regulatory submissions — from early-phase trials through to market authorisation.
Accelerate clinical trial reporting with smarter tooling — including open-source automation and GenAI-assisted workflows.
Statilyze is built to compress the time between data lock and submission-ready outputs. Agile platform configuration, open-source acceleration and AI-assisted programming reduce the manual burden on your statistical programming teams — letting them focus on analysis, not infrastructure.
A fully managed, validated environment with version control and GxP compliance built in from the ground up.
Every element of the Statilyze platform is designed with regulatory compliance at its core. The environment is validated against GxP, 21 CFR Part 11 and GAMP 5 standards — with full version control, change audit trails and controlled access to ensure your analyses are always reproducible and inspection-ready.
Deploy in the cloud or on-premises with global access for all user types — statisticians, programmers and data managers alike.
Statilyze is built to scale alongside your organisation — whether you're running a single study or managing a broad portfolio of trials across multiple geographies. Cloud or on-premises deployment options ensure data residency requirements are met, while global browser-based access means every authorised user can work from anywhere.
An open architecture that grows with you — plug in new open-source packages, SAS Viya with GenAI, and source-controlled workflows.
The statistical computing landscape is evolving rapidly. Statilyze is designed with an open, extensible architecture that accommodates new open-source packages, GenAI capabilities and emerging methodologies — without compromising the validation status of your core environment or requiring a platform rebuild every time the industry moves.
Not sure whether Statilyze is the right fit for your organisation? Our clinical computing specialists will help you assess your options.
Statilyze is backed by a team with deep roots in clinical data science, regulatory compliance and open-source statistical computing. We don't just deliver software — we become a partner in your trial delivery capability.
Our team has delivered validated computing environments for pharmaceutical companies, CROs and NHS organisations — from early-phase studies through to global regulatory submissions.
Statilyze is delivered with full validation documentation — including IQ, OQ and PQ protocols — so your IT, QA and regulatory teams have everything needed for inspection readiness from day one.
We work in SAS, R and Python every day — meaning we understand clinical statistical programming from the inside, and can support your teams with tooling choices, migration and skills development.
A specialist team focused on Statilyze deployment and ongoing support — not generalist IT helpdesks. We understand the clinical context, the tooling and the compliance requirements your organisation faces.
Statilyze is trusted by leading pharmaceutical and clinical organisations including Veramed, Orphalan, Moonlake and Simbec Orion — alongside NHS and life sciences teams across the UK and internationally.
Three straightforward steps. We handle the complexity so your team can stay focused on science.
Share your current environment, tooling and compliance requirements. Our specialists will review your position, identify any gaps and confirm a recommended Statilyze configuration — usually within a few days.
We configure and validate your Statilyze VSCE against your specific infrastructure, user roles and regulatory requirements — delivering full validation documentation alongside the platform itself.
Your teams gain access to a compliant, fully managed computing environment. We remain on hand throughout — for user support, ongoing validation activities and platform evolution as your programmes grow.
Talk to our clinical computing specialists today. We'll assess your current environment and show you what Statilyze can deliver for your organisation.