About Us
Berry Consultants ("Berry") is a scientific consulting company specializing in innovative clinical trial design, Bayesian analysis, adaptive trial implementation, and software solutions for the pharmaceutical and medical device industry.
Berry was founded in 2000 by Donald Berry, PhD and his son, current President, Scott Berry, PhD. Since then, Berry has designed thousands of innovative adaptive trials for medical device, biotech, and pharmaceutical companies. In addition to Don and Scott, Berry currently employs full-time statistical and medical scientists to precisely tailor innovative flexible designs for each client.
Berry's primary services include designing adaptive clinical trials, conducting comparative effectiveness research such as decision analysis and meta-analysis, providing strategic operational excellence and knowledge of advanced trial implementation, supporting interim analysis and trial updates during the implementation of adaptive trials, participating on Data Monitoring Committees, and the development and licensing of software solutions. These commercially available software solutions include QUOTES (Quantification and Optimization of Trial Expectations Simulator), ADDPLAN (Adaptive Design Planner), and FACTS (Fixed and Adaptive Clinical Trial Simulator) which is the most powerful, flexible, and fastest simulation tool on the market for advanced clinical trial design.
The Berry team has extensive experience in working with clinical investigators, scientific domain experts, FDA, and EMA in the design, simulation, and implementation of complex adaptive clinical trials that range from proof-of-concept studies to some of the most innovative multi-drug platform trials. These trials and related efforts by Berry have been supported by a wide range of domestic and international for-profit sponsors, US government agencies including the NIH, the Patient-Centered Outcomes Research Institute (PCORI), and government research funders in Canada, Europe, Australia, and New Zealand.
In addition, the team of statistical and medical scientists at Berry are internationally renowned leaders in the design and implementation of adaptive platform trials—complex clinical trials able to evaluate multiple treatments simultaneously and intended to continue beyond the evaluation of any one treatment, while maximizing statistical and clinical efficiency. Platform trials designed by the team at Berry are either ongoing or being initiated in oncology, infectious diseases, pulmonary and critical care, neurology, and other areas.
Our Founders and Vision
Don Berry, Ph.D., a pioneer in Bayesian biostatistics, played a critical role in bringing adaptive trials to the forefront of modern clinical research. His work with the FDA’s Center for Devices and Radiological Health (CDRH) helped establish Bayesian methodologies as a gold standard in trial design.
In 2000, Don partnered with Scott Berry, Ph.D., to co-found Berry. Together, they built a company committed to advancing the role of Bayesian statistics in the design, implementation, and analysis of clinical trials. Today, Berry leverages their extensive expertise in adaptive and Bayesian clinical trials to provide efficient and innovative solutions for medical research. The team of seasoned statistical scientists, medical scientists, and clinical trial experts collaborate closely to tailor strategies that suit unique project needs, ensuring high-quality, reliable outcomes. By utilizing cutting-edge methodologies and a wealth of experience, Berry delivers customized services that accelerate the development of therapeutic innovations, benefiting clients and ultimately improving patient lives.
