Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.
From Discovery through Development
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.
Pharsight's Consulting Services team provides high-quality, regulatory-complaint PK/PD analyses that are the basis of your regulatory submission package. On more than 100 client engagements per year, we apply our world-class expertise and technology to support nonclinical and clinical study analysis for new drug approval.
We use the latest versions of Phoenix® WinNonlin® and Pharsight Knowledgebase Server™ (PKS™) to ensure that your analyses are carried out to the highest professional standards, in minimum time, at competitive rates.
PK/PD Analysis Using Industry-Standard Phoenix® WinNonlin®
Early Clinical Studies
In Vivo-In Vitro Correlation (IVIVC) Using IVIVC Tookit for Phoenix®
Our methods are simple, efficient, and robust. You receive the highest quality analysis, leading to protocols optimized for
We work in close collaboration with Pharsight’s Medical Writing team to deliver regulatory-compliant study reports based on our analyses.