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
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
For just a few seconds, I want you to close your eyes and take a deep breath. Exhale. Now picture yourself at work in the regulatory operations and safety department of a biopharmaceutical company. It is 5:20 PM, and you and another colleague are headed out of the door for the day. You both wanted … Continued
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
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
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
