Creating unquestionable value for our partners is our #1 priority
Using modeling and simulation across the entire drug development life cycle, we help to de-risk your program, increase confidence in critical decisions, and help you reach your goals, smarter and faster. Acting as your dedicated stewards, our best-practice, quantitative systems and integrated approach delivers significant time and cost savings while accelerating regulatory and commercial success. From clinical pharmacology to pharmacometrics to regulatory submission and strategy and market access, we have 650+ leading experts throughout the world who are dedicated to achieving your goals. Build your drug development dream team with Certara.
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Pharmacometrics
Pharmacometrics uses mathematical and statistical models to quantify drug, disease, and trial information to help address critical drug development decisions.
Model-based Meta Analysis (MBMA)
MBMA is a quantitative framework that uses PK/PD and statistical modeling to leverage external clinical trial efficacy, tolerability, and safety data to inform drug development decisions.
Quantitative Systems Pharmacology (QSP)
Improve R&D productivity with QSP models, which predict how drugs modify cellular networks in space and time and how they impact and are impacted by human pathophysiology.
Quantitative Systems Safety and Toxicology
QSTS helps to characterize adverse drug reactions by describing modes of action as adverse outcomes pathways and perturbed networks versus conventional empirical end points and animal-based testing.
Simcyp Physiologically-based Pharmacokinetic (PBPK) Modeling
Our bespoke and leading PBPK modeling and simulation (M&S) consulting services help answer a range of questions without having to resort to a clinical study.
Simcyp™ Virtual Bioequivalence (VBE)
Demonstrate Bioequivalence with PBPK Modeling in Lieu of Clinical Studies
First-in-Human (FIH) Dose Prediction
Pharmacokinetics (PK) that leverage a mechanistic approach provide accurate predictions of human PK prior to phase 1 studies, resulting in significant cost and time savings of up to 6 months.
Clinical Pharmacology
Our clinical pharmacology expertise is critical for optimizing safety and efficacy in drug development. Clinical pharmacology compromises more than 50% of a drug label.
Since 2014, customers who use our biosimulation software and technology-driven services have received 90% of all new drug approvals by the U.S. Food and Drug Administration.
90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022, excluding diagnostic agents. This is the 9th consecutive year that Certara’s customers, who use the Company’s biosimulation software and technology-driven services, have had novel drugs approved by the FDA in a wide range of therapeutic indications, from oncology to rare diseases.
Regulators are on board with PBPK.
This means that the regulatory-accepted predictions from the Simcyp Simulator have enabled the sponsors of these 100 new drugs to add prescribing information to the drug label, thus eliminating costly and time-consuming clinical studies, while also expanding the potential patient population for that drug.