About Stat One
Stat One, LLC is a CRO with over 25 years of experience supporting clinical trials for pharmaceutical, biotechnology, IVD, medical device, academic, and research organizations. We also provide eClinical solutions to our clients. Our industry knowledge of over two decades combined with our focus on quality makes us an excellent choice for your partner in growing a better future. Our strong background in clinical trials along with our user-friendly technology helps our clients make the most of their time and budget. Stat One works with you to achieve your goals.
What makes us different?
Experience - Stat One team members have been involved in numerous successful submissions, provided FDA panel meeting support and assisted in FDA interactions. Our experience includes pharmaceutical, medical device, biologics and diagnostic submissions. We have a wide range of therapeutic experience including, but not limited to, CNS, Cardiovascular, Respiratory, Dermatology, Oncology, Imaging, and Orthopedic. Stat One’s participation has ranged from protocol development, representation at FDA meetings, interim and final analyses, DSMB participation, ad-hoc analyses, rescuing failing projects, to presentations at panel meetings. In addition, we are experienced in Frequentist and Bayesian methods including adaptive design approaches.
Efficiency and Execution - At Stat One, we execute every project with the client’s timeline and budget in mind. We plan accordingly to meet agreed upon due dates and adjust internally as needed.
eClinical Solutions - We believe that the choice of a data capture solution can be a crucial decision. Our eClinical solution, Stat One EDC®, focuses on being an affordable product serving a broad set of needs for a clinical trial. The Stat One EDC® system is scalable to the largest of studies, but is an ideal solution for small and mid-sized firms that need a solution that works for them.