Greater Certainty in Drug Development

Data standardization is the key to faster, more accurate analysis, resulting in successful submissions. By applying standards at the point of collection, you save time and reduce the risk of manual errors as you approach interim analyses, prepare regulatory documents, or simply make &#8220;no/no-go decisions&#8221; based on early results. But if standardization is the key &hellip; <a href="https://www.certara.com/webinar/standards-for-all-controlling-your-metadata-for-vendors-study-sites-and-submission-datasets/">Continued</a>

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 &hellip; <a href="https://www.certara.com/webinar/phoenix-winnonlin-pk-submit-industry-standard-software-for-smarter-pk-pd-workflows/">Continued</a>

This webinar is available only in Korean. &nbsp;&nbsp; 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.&nbsp; In the webinar, we will introduce how innovative technology can replace costly, resource-heavy processes with a guest speaker, Soonbeom &hellip; <a href="https://www.certara.com/webinar/cdisc-data-standards-beyond-value-korean-webinar/">Continued</a>

Pharmacokinetic/pharmacodynamic (PK/PD) modeling is a crucial aspect of drug development. PK/PD models describe how drugs interact with the body (PK) and how the body responds to drugs (PD). In this blog, we’ll discuss why machine learning for PK/PD modeling is a powerful tool to increase drug development efficiency.  The challenges of manual PK/PD model development   … Continued

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

Efficient drug development relies on informed decision-making. For toxicologists, having timely access to nonclinical study data while studies are in progress is a game-changer. Imagine the ability to monitor research findings as they develop. This change would allow you to adjust study designs in the moment and provide actionable insights to your team.   However, traditional … Continued