| Stat One | Stat One

Stat One is a specialty Contract Research Organization (CRO) providing expert statistical consulting, production programming, and data management services supporting clinical trials in the pharmaceutical, medical device, and biotechnology industries. With over three decades of industry knowledge and a focus on quality, Stat One is an excellent choice for your partner in growing a better future.

Establishing and maintaining effective and early collaboration plays a pivotal role in achieving a successful and efficient FDA approval process, as it allows for seamless coordination and communication between all parties involved, including regulatory bodies, medical device or pharmaceutical companies, and industry professionals.

Stat One has experience representing clients with the FDA in a broad range of therapeutic areas. We have been involved in numerous studies that were cleared or approved in all areas including PMAs, 510(k)s, NDAs, and BLAs.


View Stat One’s FDA Experience here:

Stat One FDA Brochure



Our team at Stat One always emphasizes the importance of early conversations when navigating factors such as study design, clinical program developments, and FDA interactions.  To speak with our biostatistical experts, contact