Stat One LLC is a specialty contract research organization (CRO) purpose-built to support pharmaceutical, biotechnology, in vitro diagnostics (IVD), and medical device companies that require rigorous biostatistics, scalable electronic data capture (EDC) solutions, and a true strategic research partner.
Dedicated to advancing clinical research through expert guidance and innovative technology, Stat One delivers comprehensive, tailored CRO support for statistical, analysis, and DM services — starting at study design through data collection, completion of statistical analysis, writing support, and generation of SDTM/ADaM/DefineXML files as needed.
By combining flexible clinical trial support, modern EDC capabilities, and deep industry expertise, Stat One helps companies achieve their clinical trial goals by identifying practical and achievable studies, improving data accuracy, completing planned analyses, and providing statistical reports or reporting as needed. Our extensive experience in support of clinical trials in the US and outside the US often allows us add useful context to client’s own interaction with regulatory agencies.
Partnering with sponsors across
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.
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.
Protocol design, Analysis Planning, Sample Size, Statistical Programming & Data Management. We have experienced internal staff, no subcontracting.
Over two decades of regulated-industry know-how, sponsor-side empathy, and quality-first habits. Supporting your path to clearance is our highest goal.
Stat One EDC® · The Platform
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.
From Protocol to Practical Strategy in 30 Minutes.
Thirty minutes with a senior statistician — no slide deck, no sales engineer. Walk away with a study-design memo and a realistic timeline.
