依托于我们 650 多名医疗保健与制药专业人员数十年来积累的深厚经验以及先进的技术解决方案，我们还提供药物开发咨询服务。这种业务组合提供了大量的药物开发见解与专业知识，从而助力客户在监管方面和商业方面获得成功，同时也节省了大量的时间和资金。过去的十年间，我们共计参与了 7,000 多个客户重点项目，积累了丰富的行业经验。
我们模型引导的药物开发量化方法能够全面展现临床与监管申报成功可能性以及新疗法所面临的挑战。我们由此获得了重要见解，从而为我们的生物模拟软件开发提供相应的信息。这些见解可帮助我们进行预测，并调整我们的技术路线图以满足我们客户的需求和优先事项。通过清晰展现开发周期中的机遇和风险，我们消除了此过程中关键里程碑上的疑虑并激发了信心。
我们的目标不仅是通过药物治疗和医疗器械突破可能存在的界限，而且还要挑战推动监管科学发展的思维。我们致力于分享我们思想领袖的见解和发现，以针对我们目前的方法提出质疑，并展望生物模拟和公共卫生的未来。
人工智能模型和 GPTs 的普及彻底改变了生命科学行业消费信息和利用信息从而加速和验证研究的方式。利用 GPTs，研究人员可以在几分钟或几小时内完成通常需要数周时间的文献查阅和数据提取任务。In this webinar, Certara’s experts will … <a href="https://www.certara.com.cn/webinar/the-state-of-ai-in-in-silico-trials-and-drug-development-the-practical-application-of-ai-in-qsp-apac-webinar/">Continued</a>
自 FDA 颁布法规要求递交的数据集需符合 CDISC 研究数据制表模型（SDTM）以来，临床试验申办方一直面临着一个难题。他们应该从一开始就按照 SDTM 设计电子病历报告表（eCRFs）吗？还是应该在最后阶段再将数据回溯性地转换为 CDISC SDTM？A retrospective … <a href="https://www.certara.com.cn/webinar/optimizing-the-quality-of-cdisc-sdtm-compliance-apac-webinar/">Continued</a>
在选择如何完成 IND 申报时，必须确定流程中的许多要素：budget, software, personnel support, and more. To further complicate matters, these components must come together in harmony to ensure a smooth filing. Instead of concentrating individual efforts on research and how to unify the process, … <a href="https://www.certara.com.cn/webinar/advancing-services-software-for-inds-how-to-expedite-ind-filing-with-a-subscription-model-apac-webinar/">Continued</a>
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Unlocking Efficiency in Drug Development with Simcyp PBPK Modeling Complex drug-drug interactions (DDIs) are a significant roadblock in drug development. While crucial for safety, traditional methods like extensive clinical trials can be time-consuming, cost millions of dollars, and delay the delivery of potentially life-saving treatments to patients in need. This white paper introduces Simcyp PBPK … Continued
This blog reviews the role of the endogenous biomarker, CP-1, for assessing OATP1B transporter-mediated drug-drug interactions and their clinical implications.
As the clinical research industry moves towards more efficient and automated processes, clinical metadata repositories are becoming a must. You’ve probably heard of them; sometimes they are referred to as ‘clinical MDRs’ or simply ‘CMDRs’. But you might not know exactly what they do and how they can make your clinical study build more efficient. … Continued
Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how these factors could delay regulatory submissions and strategic initiatives.
