Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
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The Cardiac Safety SimulatorTM (CSS) is a software solution that integrates physiologically-based pharmacokinetic PBPK modeling and simulation with a cardiomyocyte model to predict the cardiac effects of drugs. It is a standalone product and can be purchased independently of Certara’s Simcyp® Simulator.
Drug-induced cardiovascular adverse events are one of the leading causes of drug withdrawals from the market and of drug label restrictions. As a result, biopharmaceutical companies are keen to identify new drug candidates with a propensity to cause arrhythmias, or the heart to beat with an abnormal rhythm, early in the R&D cycle.
According to the ICH guideline E14, all drugs with systemic exposure must undergo a thorough QT study to investigate QTc prolongation in healthy volunteers at supra-therapeutic doses. However, TQT studies are expensive and some scientists have expressed concern that they may result in the development of some drug candidates being stopped prematurely before the drug’s entire clinical profile has been evaluated.
The U.S. Food and Drug Administration (FDA) and the Cardiac Safety Research Consortium, of which Certara is a member, are currently evaluating alternatives to the TQT study, including biosimulation approaches such as those employed using CSS. Using CSS, researchers can: