Certara, the leading biosimulation company, provides technology-enabled solutions to the global biopharmaceutical industry. We have brought together the leaders in biosimulation and regulatory writing—Pharsight, Simcyp, Tripos, Synchrogenix, and ClinGenuity —to create an integrated solution to quantitatively inform drug development.
At what dose is a drug safe, efficacious and medically differentiated? In what patient population? With what concomitant medications? We employ the largest team of PhD’s in the industry who are applying math to medicine to answer the most challenging drug development questions, with certainty and predictability.
Sounds great, but does it work? In the past three years, we have directly supported 50 new drug approvals, labels and submissions. Global regulators are now making key regulatory decisions, sometimes solely, based on the outcomes of biosimulation. Working with 1,500 companies, 6,000 scientists and leading regulatory agencies, we have substantially reduced the risk, time and cost required to get a drug to market.
Our global scientific team applies quantitative analysis and predictive models of diseases, drugs and clinical trials to support strategic decisions and new drug submissions. Our scientists combine specialized clinical and regulatory knowledge and decision-support tools to optimize patient populations and doses and regimens, design optimal trials, evaluate safety risk, extrapolate virtual human data, and create clinical study reports and filing documents to expedite the drug development process. Learn More
Solutions for modeling, simulation, and analysis, as well as scientific informatics throughout the discovery and development process. Anchored by the unique Simcyp population-based simulator and Phoenix&o® WinNonlin®, the ‘gold’ standard for PK/PD and non-compartmental analysis, our technology suite is unmatched in the industry. Virtually all the leading pharmaceutical companies and regulators, including the FDA, use our technology to affirm IND and NDA claims and to consider the substitution of biosimulation for clinical studies. Learn More