PPD has signed a license agreement to use Tessella and Berry Consultants’ FACTS software for designing adaptive and fixed trials. The software expands PPD’s adaptive design capabilities by offering greater ability to use extensive simulations to investigate various study design options. These simulations are particularly useful for adaptive designs, where different options are available for making adjustments to an ongoing trial based on a set of pre-specified conditions, which can also be used with fixed designs.
The software includes a suite of programs that has built-in facilities for simulating interim and final patient responses, patient dropouts and patient accrual. It provides a range of options for replicating both simple and complex designs, and it enables PPD to run clinical trial simulations on certain characteristics of competing designs.
“FACTS is a powerful tool that will enhance our ability to deliver flexible, efficient adaptive trial designs for our clients in less time than we could previously,” said Susan Atkinson, Ph.D., PPD’s senior vice president of global biometrics. “The simulations generated by this software will help us create richer designs so that our clients can make better informed decisions about their trials. This agreement also demonstrates our commitment to enhancing our position as a leader in adaptive trial design among full-service contract research organizations.”