About Us

Certara is dedicated to improving human health by offering a broad spectrum of software products and services, with special focus on supporting translational approaches to drug development.

Scientific Informatics

Access, visualize, and analyze drug discovery, pre-clinical and clinical data

D360

Molecular Modeling and Simulation

Predictive science for drug discovery and other life sciences

PBPK Modeling and Simulation

Conduct simulations in virtual patient populations based on in vitro and clinical data.

PK/PD Modeling and Simulation

Analyze, manage, report, and validate preclinical and clinical data.

Trial Design

Minimize risks and guide decision making for drug trials.

Trial Simulator

Discovery Through Phase IV Clinical Trials

Pharsight Consulting Services

Support your strategic drug development decisions and new drug approvals through quantitative analysis and predictive models of diseases, drugs and clinical trials.

Simcyp Consultancy Services

Consultancy and guidance on a broad spectrum of DMPK issues, including optimal design for metabolic drug-drug interaction studies, interpretation of data and prediction of in vivo ADME from in vitro studies.

PBPK Modeling and Simulation

Our Practice

Multi-disciplinary expert scientific team with expertise in pharmacometrics, PK analysis and programming, biostatistics, and medical writing.

Model-Based Insights, Unparalleled Experience

Supporting Drug Approvals

Our team of more than 50 scientists has supported eleven drug approvals in the last two years.

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Resource Library

Search Certara's Resource Library to find papers, presentations, and webinars of interest

SEARCH RESOURCES

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Consulting

Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.

Case Studies

Our global Consulting Services team has unparalleled experience across all development phases and in all major therapeutic areas, spanning 80+ disease indications and 130 drug classes. We have collaborated with clients to support key trial design and program-level development decisions at every point along the regulatory timeline.

We've highlighted a few key case studies here - just click the title to get the PDF. To find more case studies and other publications, explore our Resource Library at the bottom of the page, or contact us today to discuss your interests with one of our experts.

Alzheimers Case Study: Modeling and Simulation Supports Competitive Dose Assessment and Go-No Go Decision
Diabetes Case Study: Modeling and Simulation Supports Competitive Product Profile Assessment and In-Licensing Decision
Oncology Case Study: Modeling and Simulation Supports Dose Justification and Post Approval Commitment
Optimal Dose Case Study: Model Development and Trial Simulation Supports Dosing Decision
CNS Case Study: Modeling and Simulation Supports Pivotal Trial Strategy and Accelerates Clinical Development

Videos

Introduction to Certara Consulting Services - helping 11 new drugs get approved in the last two years

Certara’s Pharsight Consulting Services is applying quantative models to decision making, helping accelerate FDA approvals

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Key Publication

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.

Simulations Using a Drug-Disease Modeling Framework and Phase II Data Predict Phase III Survival Outcome in First-Line Non-Small-Cell Lung Cancer
Claret L, Lue JF, Bruno R, Hsu CP, Hei YJ, Sun YN. Clinical pharmacology & Therapeutics (2012).
Advance online publication 22 August 2012. doi:10.1038/clpt.2012.78.

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