The Utility of Model-Informed Drug Development for Rare Diseases

Model-informed drug development (MIDD) is a network of closely integrated ecosystems that can seamlessly position a new drug candidate while minimizing uncertainty in technical and regulatory success. Indeed, MIDD affords rational scientific hypothesis testing while enabling the clinical development program using strategic pillars. These strategic pillars form a core component of an innovation ecosystem (Figure … Continued

Certara Earns 2022 Great Place to Work Certification™

Princeton, NJ, May 17, 2022.  Certara, Inc., a global leader in biosimulation, today announced that the Company was Certified™ by Great Place to Work® in its first year of participation.  The prestigious award is based entirely on what current employees say about their experience working at Certara. This year, 88% of employees said it’s a … Continued

Ask Me Anything: Career Opportunities in Regulatory & Medical Writing

June 8, 2022 – 11am ET Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry? Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory). Our team is growing, … Continued

Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use.  During the webinar, we will present a framework for qualification of the Simcyp … Continued

Certara Reports First Quarter 2022 Financial Results

PRINCETON, N.J.—May 5, 2022– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2022. First Quarter Highlights: Revenue was $81.6 million, compared to $66.7 million in the first quarter of 2021, representing growth of 22% over the first quarter of 2021. Excluding Pinnacle … Continued

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