Berry Consultants, Llc

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'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.