PRINCETON, N.J.–(BUSINESS WIRE)–Certara®, the global leader in model-informed drug development,
regulatory science, real-world evidence and market access, today
announced the launch of version 2.3 of its Trial Simulator software to
help drug developers improve clinical trial design, resulting in greater
likelihood of trial success. By allowing users to model and simulate
different clinical trial scenarios, Certara’s Trial Simulator® allows
them to identify and assess risks and preview the range of expected
results before millions of RD dollars are spent and human subjects are
exposed to experimental therapies.
Today, nine out of 10 drugs in development fail to make it to market,
costing pharmaceutical companies billions of dollars every year.1
Even the majority of drugs that get to Phase 3, do not get approved.2
One reason for trial failures is suboptimal trial design.1,2
“Certara’s Trial Simulator is a trusted solution that has been used by
leading pharmaceutical companies for more than a decade to optimize
their clinical trial design and maximize their probability of trial
success. But as these trial failure rates testify, we need to increase
awareness of trial simulation’s capabilities and broaden its adoption.
Meanwhile, we continue to enhance Trial Simulator both to support our
loyal customers and ensure that the platform continues to meet their
evolving needs,” said Thomas Kerbusch, PhD, president of Certara
Strategic Consulting Services.
Trial Simulator provides an easy-to-use and highly efficient approach to
computer-assisted clinical trial design. Drug development teams can use
Trial Simulator, together with existing drug knowledge, to answer highly
pertinent questions such as: How likely is this trial to succeed? What
is the optimal dosing and treatment schedule for a particular
indication? What is the expected range of responses across doses? How
will a change in patient inclusion/exclusion criteria affect outcomes?
Can we shorten the trials or reduce the number of patients in the trials?
With Trial Simulator, drug development teams can define study design
attributes, conduct statistical and sensitivity analyses, and create
graphical summaries of their work. They gain access to Certara’s
extensive library of pre-built pharmacokinetic, and
pharmacokinetic/pharmacodynamic (PK/PD) models, which allows them to
rapidly build population-based drug and disease models that describe
drug actions over time in specific subjects. They can even create novel
study designs and compare different development strategies. With Trial
Simulator, users can share their scientific knowledge, test ideas, and
plan the most relevant, effective clinical trials.
Furthermore, Certara‘s Trial Simulator v2.3 is highly intuitive and easy
to use. It combines comprehensive modeling of drug action with an
easy-to-use graphical interface and seamless connection to R for custom
plotting capabilities. The debugging tool creates real-time plots of any
variable in the drug model, including concentration and effects over
time. Trial Simulator 2.3 also supports a wide variety of trial designs,
including parallel, n-by-n Latin square, and crossover designs. To make
the entire process as efficient as possible, Trial Simulator includes
built-in analysis routines such as descriptive statistics, ANOVA,
ANCOVA, bioequivalence analysis, and the Kaplan-Meier survival analysis.
Interested parties, who would like to see Trial Simulator in action, can
access a one-hour archived webinar entitled “Using Realistic Covariates
with New Trial Simulator to Optimize Meropenem Dosing in
Renally-impaired Children” at https://www.certara.com/webinar-archive/using-realistic-covariates-with-new-trial-simulator-to-optimize-meropenem-dosing-in-renally-impaired-children.
This webinar was co-presented by Dr. Edward Nehus, a pediatric
nephrologist in the Division of Nephrology at the Cincinnati Children’s
Hospital Medical Center and an assistant professor at the University of
Cincinnati, Department of Pediatrics, and Dr. Mark Lovern, vice
president of Integrated Drug Development at Certara.
1. Lo C. (2017, June 19). Counting the cost of failure in drug
development. Retrieved from https://www.pharmaceutical-technology.com/features/featurecounting-the-cost-of-failure-in-drug-development-5813046.
2. Grignolo A Pretorius S. (2016, August 1). Phase III trial failures:
Costly, but preventable. Retrieved from http://www.appliedclinicaltrialsonline.com/phase-iii-trial-failures-costly-preventable.
Certara enables superior drug development and patient care
decision-making through model-informed drug development, regulatory
science, real-world evidence solutions and knowledge integration. As a
result, it optimizes RD productivity, commercial value and patient
outcomes. Its clients include hundreds of global biopharmaceutical
companies, leading academic institutions, and key regulatory agencies
across 60 countries. For more information, visit www.certara.com.