How to Chart an FDA Regulatory Strategy for Expedited Drug Approval

January 24, 2019
Developing a regulatory strategy for an investigational drug can seem like a daunting task. There are so many critical decisions to be made. What data must be collected? Are there biomarkers that can be used as potential surrogates of drug safety or efficacy? What is the best regulatory pathway to pursue? The consequences of a suboptimal...


Simulating Viral Dynamics in the New Trial Simulator

February 28, 2019
Certara’s Trial Simulator software provides a powerful approach to computer-assisted trial design, balancing ease of use with robust tools for defining design attributes, conducting statistical and sensitivity analysis, and creating graphical summaries to plan effective trials for every phase of clinical drug testing. While it provides an...


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