StatOne Contract Research Organization

Let your data grow.

Stat One is a CRO purpose-built for pharmaceutical, biotech, IVD and medical-device teams who need rigorous statistics, scalable EDC, and the kind of partnership that doesn’t come standard.

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Partnering with sponsors across
Pharmaceutical     Biotechnology     IVD Diagnostics     Medical Device     Academic Research

Three ways to move studies forward

Whether you need a complete CRO partner or a single capability, our teams plug in cleanly — software, statisticians, and program managers who’ve sat on every side of a sponsor’s table.

  • StatOne EDC System

    A 21 CFR Part 11–validated electronic data capture platform that scales from a 40-patient pilot to a global registry. Built by statisticians who actually use it.

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  • Consulting Services

    Protocol design, SAP authoring, sample-size justification, programming, data management. Senior statisticians on every engagement — not subcontracted.
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  • Why Choose Stat One?

    Two decades of regulated-industry know-how, sponsor-side empathy, and quality-first habits. We win when your study wins, full stop.

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Stat One EDC® · The Platform

Electronic data capture, scaled for studies that change.

Built and validated in-house, Stat One EDC® supports paper studies, registries, and complex EDC builds — without the licensing tax of legacy platforms. Configure faster, lock cleaner, ship reports the day database lock closes.
  • 21 CFR Part 11 validated
  • Status, lock & disable controls
  • Decode & variable templates
  • Role-based study access
  • Coding library integration
  • Audit-ready by design
See It In Action
Stat One EDC Form Builder
StatOne EDC System

Talk to a statistician…

Bring us a protocol. We'll bring options.

Thirty minutes with a senior statistician — no slide deck, no sales engineer. Walk away with a study-design memo and a realistic timeline.

Book a 30-Min Intro