CATO SMS was formed in 2019 by the merger of two high-performance specialty CROs: Cato Research and SMS-oncology.

Cato Research, founded in 1988, was known for its ability to design and execute successful development strategies and guide creative new products through the regulatory process. SMS-oncology, founded in 2007, was a specialty oncology CRO recognized for delivering a complete range of clinical trial services and providing strategic consulting to companies developing anticancer drugs. Now, as a fully integrated global company, CATO SMS delivers innovative strategies and robust solutions based on over 30 years of background in regulatory insight, therapeutic experience, and operational expertise.

In September 2020, CATO SMS acquired Array Biostatistics to expand our biostatistical consulting, analysis and programming services and expand our available solutions to support our clients’ drug development needs.

With offices across North America, Europe, and the Middle East, CATO SMS has experience conducting trials in more than 25 countries, focusing on some of the most complex development areas including oncology, rare and orphan indications, and cell and gene therapies. Globally, CATO SMS has worked on more than 500 clinical trials, with oncology representing the majority.

We are your go-to partner, designed to serve small and emerging biopharma, while focusing on complex indications and modalities.