FACTS 8 introduces support for Ordinal endpoints and a new “Quick Start” feature

Berry Consultants, LLC announced the release of FACTS 8, the latest version of its industry-leading Fixed and Adaptive Clinical Trial Simulator (FACTS). FACTS 8 is now available to both existing users and new clients worldwide.

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FACTS is the most powerful, flexible, and efficient platform for designing and simulating clinical trials across the full spectrum of drug development — from early Phase I studies to complex, multi-arm platform trials. The new release introduces two major advancements:

• Full simulation of ordinal endpoints in Phase II and Phase III trial designs, enabling powerful designs with frequentist and Bayesian methods of analysis.
• A Quick Start feature that streamlines setup for fixed and group sequential trials while maintaining the full simulation power FACTS provides for more customized adaptive designs.

“Ordinal endpoints are ubiquitous in clinical trials and the ability to optimize the analyses and design for trials utilizing them is becoming increasingly important,” said Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants. “With FACTS 8, we’re giving researchers a unified platform to evaluate and compare analytical methods for these endpoints — from dichotomization, non-parametric Wilcoxon tests, proportional odds testing, Bayesian Dirichlet models, to utility weighting. This capability allows teams to directly compare performance, make better design choices, and ultimately improve clinical research.”

The Ordinal Endpoint Module in FACTS 8 supports simulation of one-, two-, or multi-arm trials and includes the full range of adaptive design features — early stopping, arm dropping, and response-adaptive randomization.

“This release not only extends the power and range of FACTS, but also makes simulation of conventional trials faster and easier,” added Tom Parke, Director of Software Solutions at Berry Consultants. “The new Quick Start feature allows users to set up and run standard designs in minutes, while retaining the same detailed simulation engine that powers our most advanced adaptive trials.”

With these enhancements, FACTS continues to reflect Berry Consultants’ philosophy that clinical trial simulation should be intuitive, transparent, and comprehensive. FACTS enables users to specify and compare designs across the entire range of trial types — from simple fixed designs to the most innovative adaptive platforms — supporting smarter and more efficient clinical development.

About Berry Consultants

Berry Consultants is an internationally recognized leader in the design, simulation, and implementation of innovative clinical trials. Founded in 2000, the company specializes in Bayesian and adaptive clinical trials and provides both consulting expertise and software solutions to pharmaceutical, biotechnology, and academic partners worldwide. Through its flagship FACTS software platform, Berry Consultants empowers researchers to explore, optimize, and execute trial designs that improve efficiency, ethics, and scientific insight across therapeutic areas. www.berryconsultants.com

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