We specialize in the building of Bayesian trials for drugs, medical devices, and biologics. Almost all the trials we build are adaptive. We have been building adaptive designs before it was the “in thing to do” because we, along with our clients, see that it is the most efficient, effective, way to conduct clinical trial designs. We are a specialty statistical consulting company designing the most innovative and efficient designs in the industry. We do not do routine statistical consulting and design.
We also specialize in Bayesian analysis. We specialize in the application of Bayesian hierarchical models, meta-analysis, and decision analysis. These methods have become very popular in the growing field of comparative effectiveness (CE) research. Bayesian tools are natural in CE research.
Most non-trivial Bayesian analyses demand skilled and experienced modeling, and typically entail a significant computational effort that usually require deployment of customized software. We can help if you have a decision to make, uncertainty about how to best craft a development strategy, or a clinical trial to design.
The role of the prior in a Bayesian analysis is very important—whether the purpose is to model a clinical team’s views or to represent an outside agent’s (regulatory, clinical practice, payers, etc.) point of view. We have had experience with the selection, elicitation, and defense of prior distributions in hundreds clinical trial designs.
We frequently create unique software for our design and analysis projects. The ability to design new software for your needs makes us ideally suited to tackle the toughest and most challenging biostatistical problems.
Clinical trial simulation has become incredibly important in the evaluation of trial design, drug development strategy, and for the execution of clinical trials. Berry Consultants has become the industry leader in clinical trial simulation. The FACTS platform for clinical trial simulation is the most sophisticated, advances, trial design simulation tool on the market. The tool is incredibly valuable for exploring trial design, evaluating the value of a trial to the development process, understanding the efficiency of a design, and for justification of a design to regulatory authorities. The ability to ‘flight simulate’ a design through simulation itself is an incredibly valuable tool and is mandatory in the design of adaptive trials.
If you have a challenging design, simulation, or analysis that could use our services (or need training for your organization in these areas), please contact us.