More than 30 years of clinical, statistical and regulatory expertise.
Stat One is a trusted Contract Research Organization (CRO) with more than 30 years of experience supporting clinical trials for pharmaceutical, biotechnology, IVD, medical device, and research organizations. We provide expert biostatistics, statistical programming, data management, and eClinical solutions designed to help clients bring products to market efficiently and confidently.
Our team has contributed to numerous successful regulatory submissions and has extensive experience supporting interactions with the U.S. Food and Drug Administration (FDA). We have provided strategic guidance for FDA meetings, panel presentations, interim analyses, final study analyses, Data Safety Monitoring Board (DSMB) activities, and complex ad hoc statistical evaluations.
Our expertise spans pharmaceutical products, biologics, medical devices, diagnostics, and combination products across a broad range of therapeutic areas, including:
From protocol development and adaptive trial design to regulatory submission support and project recovery, our team delivers the scientific rigor and practical experience needed to support successful clinical development programs.
