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CDISC data standards – Beyond value [Korean Webinar]

This webinar is available only in Korean.    The Pinnacle 21 Enterprise next-generation cloud suite optimizes the end-to-end clinical trials process. Increased efficiency, higher data quality, and improved data flow across stakeholders are now at your fingertips.  In the webinar, we will introduce how innovative technology can replace costly, resource-heavy processes with a guest speaker, Soonbeom … Continued

Phoenix NLME & Pirana: Powerful popPK Modeling Software for Streamlined Pharmacometric Workflows

Pharmacometric models are increasingly used in drug development to guide decision-making. Pharmacometricians need the right tools to optimize this workflow that turns data into decisions for complex development scenarios.  Our webcast explores key challenges in popPK modeling and introduces workflows using Certara’s Phoenix NLME and Pirana to streamline complex analysis tasks. This session is ideal … Continued

How the US FDA MIDD paired pilot program helps sponsors

For the past couple of decades, leading American institutions, pharmaceutical and biotechnology companies, as well as the US FDA have been using quantitative tools (model-informed drug development; MIDD) to further their understanding of drug development assets. This integrated armamentarium has fueled industry consortiums, public-private partnerships, as well as several regulatory guidance documents. In this blog, … Continued

Phoenix WinNonlin & PK Submit: Industry-Standard Software for Smarter PK/PD Workflows

As a PK/PD researcher, you need software that accelerates and supports your drug development program, enabling efficient completion of essential tasks like NCA. Phoenix WinNonlin, with its integrated tools for data preparation, analysis, quality control, graphing, and CDISC-compliant reporting, provides reproducible workflows that streamline collaborative and regulatory-compliant PK/PD research. Coupled with PK Submit, which simplifies … Continued

PBBM Educational Webinar Series (Part 1): The Basics of Drug Absorption in Drug Development – Why is Drug Absorption Essential? [Japanese Webinar]

This educational webinar series will be available only in Japanese. Research and development of mechanistic drug absorption models are advancing, contributing to the efficient development of new and generic drugs. Certara has developed absorption models in Simcyp Simulator. Some case studies of successful regulatory submissions have used Physiologically-based Biopharmaceutics Model (PBBM) approaches. The authorities start … Continued

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

Disease activity scores are efficacy endpoints in clinical trials of inflammatory bowel disease (IBD) therapies. Crohn’s disease activity index (CDAI), Mayo endoscopic score (MES) and Mayo score are frequently used in clinical trials. They rely on either the physician’s observation of the inflammatory state of the patient’s gastrointestinal tissue alone or combined with the patient’s … Continued

Certara Reports Fourth Quarter 2024 Financial Results

Issues Full Year 2025 Financial Guidance RADNOR, PA – 2025年2月26日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ(Nasdaq:CERT) はCERT), a global leader in model-informed drug development, today reported its financial results for the fourth quarter and full year 2024. Fourth Quarter Highlights: “We are pleased with our fourth quarter results, which reflect solid performance in our core biosimulation … Continued

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