About Us

Berry Consultants is a statistical consulting company specializing in innovative clinical trial design, analysis, execution, and software solutions for the pharmaceutical and medical device industry. Berry Consultants’ 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 execution of adaptive trials, participating on Data Monitoring Committees, and licensing FACTS (Fixed and Adaptive Clinical Trial Simulator) software which is the most powerful, flexible, and fastest simulation tool on the market for advanced clinical trial design.

The Berry Consultants 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 clinical trials designed by Berry Consultants have been accepted and approved by the FDA, including by the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). These trials and related efforts by Berry Consultants 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 Consultants 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 Consultants are either ongoing or being initiated in oncology, infectious diseases, pulmonary and critical care, neurology, and other areas.