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Modeling the Effects of Genetic Variation with Trial Simulator

Computer simulation provides an effective means for evaluating whether a clinical trial design is efficient and optimally informative with a high likelihood of success. Many variables affect the likelihood of success of a trial, and genetic variation in the population is being evaluated with increasing frequency for its impact on trial outcomes.

Solution: Clinical Trials Simulation
Therapeutic Area: Infectious Disease
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Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Author(s): Alice Ke, Andrzej Kierzek, Angela Colbers, Barry Mangum, Behtash Bahador, David Turner, Ellen Leinfuss, Graham Scott, Iain Gardner, Julie Bullock, Leon Bax, Lora Killian, Maria Saluta, Nathan Teuscher, Nirpal Singh Virdee, Oliver Hatley, Peter Bonate, Rob Connelly, Ronette Gehring, Shriram Pathak, Shuhua Hu, Stacey Tannenbaum, Steve Sibley, Suzanne Minton, Tom Snowden
Solution: Clinical Pharmacology Strategy, Clinical Transparency & Disclosure, Clinical Trials Simulation, Drug Development & Regulatory Strategy, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Scientific Informatics, Systems Pharmacology
Therapeutic Area: Central Nervous System, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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Changing the Game in Drug Development

At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and unlock millions of dollars in R&D savings.

Solution: Drug Development & Regulatory Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
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