EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the time to say goodbye to EudraCT and hello to the new Clinical Trial Information System (CTIS). CTIS will be the single entry point for submitting, assessing, authorizing, supervising, and reporting clinical trials in all EU Member States (Figure 1). It … Continued
https://www.certara.com/blog/ctis-europe-new-clinical-trial-information-system/会場：Suzhou Adock Innovation Center (1F Multi-function Lecture Hall, Adock Innovation Center, No. 328 Xinghu Street, Suzhou Industrial Park, Suzhou, China) Overview: With the rapid development of technology, AI technology has penetrated all aspects of our lives. In the field of drug research and development, the combination of AI and biosimulation has brought revolutionary changes … Continued
https://www.certara.com/live-events/ai-enabling-biosimulation-innovating-the-path-of-drug-research-and-development/When you think of clinical data standardization, you might think of forms and datasets, or of CDISC’s CDASH, SDTM and ADaM models. And while these are an excellent and necessary starting point for standardization, it’s important to understand the many other ways you can use standardization to improve the efficiency of your clinical trials. Clinical … Continued
https://www.certara.com/blog/why-are-clinical-data-standards-essential-for-edc-and-non-edc-data/会場：Certara UK OfficesLevel 2-Acero1 Concourse WaySheffieldUnited Kingdom Online registration is available until: 6/29/2024 The workshop is neither trying to provide a 101 course on LCMS proteomics nor attempts to focus on what is new in LC-MS proteomics techniques. Attendees need to have some background but not necessarily leading experts in the field.
https://www.certara.com/live-events/issx-workshop-on-quantitative-lc-ms-ms-proteomics/On-site Workshop Overview Regulatory approval procedures are becoming increasingly stringent and time-consuming. 適切な規制対応戦略を未構築のままでは、多くの時間と費用の浪費するだけでなく、最悪の場合には、開発計画の失敗や大幅な遅延に繋がる恐れがあります。It relayed to potential of Generative AI how it can help overcome those regulatory challenges. The emergence … Continued
https://www.certara.com/live-events/certara-regulatory-workshop-in-korea/Agenda features discussion of life sciences industry trends, business value of model-informed drug development strategies, and impact of generative AI on biosimulation and regulatory sciences RADNOR, PA– April. 18, 2024 – 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 announced that it will host the first-ever Certainty Conference. At this event, … Continued
https://www.certara.com/announcement/certara-announces-inaugural-client-conference-with-keynote-by-dr-scott-gottlieb/希少疾患における新たな治療薬の開発は、チャンスと複雑さの両方をもたらします。Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration. The top 3 critical downfalls in rare diseases development include Poor understanding of … Continued
https://www.certara.com/white-paper/the-challenges-and-opportunities-of-rare-disease-drug-development/
