Product Overview
FACTS (Fixed and Adaptive Clinical Trial Simulator) is the industry’s most powerful tool for adaptive and fixed trial design. It enables biostatisticians to design, simulate, and optimize trials with speed and precision, reducing risk and driving innovative, data-driven decisions. Over half of the top 20 largest pharmaceutical companies in the world and more than 30 academic institutions have FACTS to assist them in the design, simulation, and implementation of trials.
Innovative designs, faster decisions: Run thousands of simulations in minutes to refine trial designs, understand uncertainty, and make data-driven decisions with confidence.
Versatility across trial phases: From early phase dose escalation to huge post-approval studies, design and optimize a trial for any phase – all in one powerful tool.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
Comprehensive Clinical Trial Design Capabilities
FACTS features dedicated engines for key trial types, supporting the most critical elements of clinical trial design, including:
- Dose Escalation Trials: Model dose tolerability and efficacy with a Bayesian CRM or find the maximum tolerated dose with a deterministic escalation strategy like mTPI.
- Dose Finding Trials: Model dose-response relationships and adaptively allocate to determine optimal dosing strategies for multi-arm Phase 2 trials.
- Adaptive Phase 3 Trials: Design adaptive pivotal trials with early stopping for success and futility based on frequentist or Bayesian quantities.
- Seamless Phase 2/3 Designs: Design a phase 2 dose finding trial that seamlessly morphs to a phase 3 study at an interim analysis. Add complexity wherever you would like it with separate tailored adaptations in each phase.
- Platform Trials: Design and simulate an adaptive platform trial with a shared control arm which treatments can continuously enter and leave.
- Multiple Endpoint Trials: Simulation multiple endpoints per subject and design an adaptive trial intended to optimize your specified utility function.
- Enrichment Designs: Target specific subpopulations and adaptively modify the enrolling population to maximize trial efficiency and impact..
These engines empower teams to test design decisions before trials begin, allowing them to refine approaches, reduce risk, and maximize efficiency. By running thousands of simulations, teams can see how different trial elements impact outcomes, identify the most effective strategies, and build more efficient, effective trials.
About the company
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 was founded in 2000 by Donald Berry, PhD and his son, current President, Scott Berry, PhD. Since then, Berry has designed thousands of innovative adaptive trials for medical device, biotech, and pharmaceutical companies. In addition to Don and Scott, Berry currently employs full-time statistical and medical scientists to precisely tailor innovative flexible designs for each client.
