Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.
From Discovery through Development
“You have set up the perfect scenario for us. We can now predict single- and multiple-dose exposure across a range of dose levels and dose frequencies. This is a much more powerful way for us to select dosage regimens than could be gleaned from a review of the individual data sets. This is very nice work!”
- Mark Fineman, PhD Vice President, R&D Elcelyx Therapeutics, Inc.
Pharmacometrics optimizes the use of Phase II data to support Phase III success.
Supporting Thirteen Recent Drug Approvals with Model Based Drug Development
Certara’s Pharsight Consulting Services is applying quantative models to decision making, helping accelerate FDA approvals.
Using an Exposure-Response driven Tumor Growth Inhibition model based on Phase II data to demonstrate non-inferiority of an unobserved dose in Phase III.
For more than 15 years, our scientists have provided a unique combination of insight and innovation building quantitative models of diseases, drugs (PK/PD) and clinical trials. Once developed, the value of these integrated models comes in using them to design, test and explore various untested clinical scenarios through computer-based simulation. Our core offerings and expertise support dose selection, trial design, labeling and strategic program decisions (e.g., go/no-go).
Disease-Drug-Trial Modeling and Simulation
Regulatory-Compliant Population PK/PD Analysis
Special Populations: Pediatrics, Rare Diseases
Cardiac Safety: QT assessment, TQT design and analysis
Product Profile Assessment: Clinical Utility Index (CUI®) modeling
The benefits of quantitative drug-disease-trial modeling and simulation have been well demonstrated by FDA and industry sponsors. Contact us today to see how we can help you achieve tangible benefits for your development programs, such as: