Certara offers predictive science and informatics solutions that enable cross-disciplinary and translational approaches to drug development.

Trial Design


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This webinar demonstrated how Certara's Pharsight Consulting Services uses Trial Simulator and Phoenix NLME to meet the FDA's Pharmacometrics criteria for pediatric drug development.

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Pharsight® Trial Simulator

Testing “What-if” Statements

The Pharsight Trial Simulator provides efficient and powerful process for drug development teams to test proposed clinical trials in a series of "what if" scenarios, and helps minimize risks and guide decision making by formalizing assumptions and quantifying uncertainties about the drug being investigated and upcoming trials.

Pharsight Trial Simulator balances ease-of-use with patented technology (U.S. Application No. 7,043,415) for defining and testing interactive drug models, exploring and communicating study design attributes, and performing statistical and sensitivity analysis through graphical and statistical summaries. Pharsight Trial Simulator helps you to anticipate risks and preview the range of expected results before R&D dollars are committed to further development of a drug, and human subjects are exposed to experimental therapies.

Development team members of diverse disciplines use the Pharsight Trial Simulator to conduct a series of simulations comparing different trial, patient and drug activity scenarios. By varying simulation input parameters, your team can test the impact on trial results of changes in known information, assumptions about the drug and subjects, and variations in the trial design. Simulation addresses questions such as:

  • How likely is trial success?
  • What is the optimal treatment schedule for a particular indication?
  • What is the expected range of responses across doses?
  • How will a change in inclusion/exclusion criteria affect outcomes?
  • How frequently should the response be measured?
  • What is the impact of poor compliance or concomitant disease?

Key Benefits

Build More Informative Trials

Test trial designs against expected drug and subject characteristics to predict the probability of success.

Capture and Communicate “Knowns” and “Unknowns” About Your Drug

Trial Simulator models predict subject responses from subject, drug and disease characteristics.

  • Your modeling team and/or expert consultants (like Pharsight Consulting Services) build the drug model based on real data—your internal studies, literature data and public databases—using Phoenix® NLME or Phoenix® WinNonlin® and similar model fitting tools.
  • Probability distributions in the models capture variability and uncertainty in key model features, including trial-to-trial variation, between- and within-subject variation, measurement error and other unexplained variability, as well as confidence intervals on expected outcomes.

Know the Range of Probable Trial Outcomes

Repeated, Monte-Carlo simulation of each Trial Simulator scenario generates a distribution of the most likely outcomes, so you know not only the most likely subject and trial outcomes, but also the confidence bounds on those outcomes.

Compare Trial Designs Across a Range of Assumptions

Trial Simulator’s simulation scenarios and replicate-level variability allow your modeling team to simulate outcomes based on different trial design and model settings, reducing the likelihood of failed trails.

  • Compare different dosing or sampling schemes, trial sizes or analyses.
  • Test your designs against different possibilities for drug potency, subject recruitment or disease severity.

Update Your Simulation With New Information

New data are easily incorporated by editing the drug model, or swapping in alternate model segments.

Minimize Risks and Guide Decision Making

As knowledge accumulates in your Trial Simulator models, the uncertainty in outcomes decreases.

  • Know how likely your trial is to succeed.
  • Avoid surprises by simulating a variety of possible subject, disease and drug scenarios.

Flexible Trial Design

  • Specify treatment protocols, inclusion criteria, and observations.
  • Define realistic subject populations through covariate distribution models.
  • Define compliance and dropouts based on drug effects or time.
  • Model variability in the actual time doses are taken or observations are made.

Powerful Modeling

  • Model drug effects as a function of dose(s), disease processes, time and subject characteristics.
  • Estimate measurement error as well as biological and unexplained variability.
  • Use the patented, component-driven graphical interface for rapid, intuitive modeling.
  • Rely on a broad library of pre-defined model components or write your own FORTRAN.
  • Automate simulations through Visual Basic or other scripts.
  • Save models as editable text files or XML.
  • Swap and test model segments using "include sets."
  • Compile simulation models through Compaq Digital Fortran, or Intel Visual Fortran.

Integrated Analysis Tools

  • Special version of S-PLUS Professional for Trial Simulator included.
  • Perform descriptive statistics, ANOVA, survival analysis, and custom S-PLUS analyses on each trial replicate and as meta-analysis across replicates.
  • Plot results through a connection to S-PLUS (provided with the tool).
  • Save simulation output in a Microsoft Access database or performance-enhancing binary format.
  • Export data to use with R, SAS, S-PLUS®, Phoenix® NLME, Phoenix® WinNonlin®, NONMEM® and more.

System Requirements

Pharsight Trial Simulator is intended to be used with 32-bit versions of Windows XP or Windows 7 SP1.   

Detailed system requirements, including required compilers and compatibility with third-party software, can be found in the Trial Simulator Requirements document.