Expertise Behind Every Decision.

Strategic statistical and clinical guidance from study design through submission.

Your Consultative Contract Research Partner

At Stat One, we are dedicated to advancing your clinical research through expert guidance and innovative solutions. As a consultative contract research organization (CRO), we provide comprehensive, tailored services to support every phase of your study, from initial planning to regulatory submission.

- CONSULTING SERVICES -

Comprehensive Clinical Research Support

Stat One provides consultative expertise across study design, analysis, regulatory support, data management an secure EDC hosting. Our services include…

Statistical Consulting - StatOne

STATISTICAL CONSULTING

Study design, analysis, and interpretation from statisticians who have defended the work in front of FDA.
Planning & Analysis - StatOne

PLANNING & ANALYSIS

Analysis plans, sample size, and interim looks built to hold up under review.
FDA Representation - StatOne

FDA REPRESENTATION

We sit at the table for agency meetings, advisory panels, and monitoring board deliberations.
StatOne Data Management

DATA MANAGEMENT

Clean, query-resolved, submission-ready data with an audit trail that stands.
StatOne EDC Hosting

EDC HOSTING

Your study on Stat One EDC®, hosted and validated by the people who built it.

Why Partner with Us?

Every clinical study is unique, which is why Stat One delivers customized CRO solutions tailored to your specific research goals and workflows. Our team combines deep expertise in clinical research, biostatistics, data management, and regulatory affairs to provide flexible, efficient support across every phase of your study.

Committed to quality, accuracy, and compliance, Stat One helps sponsors achieve reliable, reproducible results while streamlining operations and maintaining regulatory readiness. From statistical consulting and FDA support to scalable EDC and data management solutions, we provide the expertise and technology needed to advance your research with confidence.

  • Customized Solutions – No fixed service tiers. We scope to your protocol, not to a package.
  • Depth of Experience – Senior statisticians on your file from day one, not after escalation.
  • Commitment to Quality – Reproducible results, documented decisions, inspection-ready throughout.
Why Choose StatOne

- Thirty minutes, one statistician -

Bring us a protocol. We'll bring options.

A senior statistician reads your protocol before the call and comes with questions. You leave with a short design memo and a timeline we’d stand behind.