Aptiv Solutions offers fully validated software and technology solutions for the design, simulation of adaptive clinical trials.
FACTS clinical trial design and simulation software is an ideal solution for the design of early phase adaptive trials.
Our experts are able to assist sponsors in the development of advanced trial designs in a rapid stepwise process, selecting various study options and performing rapid simulations across multiple study scenarios. This allows the evaluation of different design features to assess optimal parameter settings and explore how these simulations will impact study performance.
With FACTS, Aptiv Solutions enables clients to design more efficient phase I and phase II trials that can save millions of dollars in early phase development, and, importantly, make better decisions on the selection of dose, endpoint and patient population for phase III.
ADDPLAN DF is based on MCPmod methodology and covers model-based dose-finding designs for proof-of-concept testing and estimation of target doses in phase II clinical trials. MCPmod methodology is a preferred tool for dose-finding studies although until now fully validated design and analysis software has not been available. ADDPLAN DF will allow researchers to establish a dose response signal based on a set of candidate models while strongly controlling the type I error, an important step in maintaining trial validity.