Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus Blog Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus Streamline your SDTM mapping with Pinnacle 21 Enterprise. Discover how innovation and efficiency enhance data…Certara2025 年 8 月 13 日
Increasing Productivity In Pharma R&D Starts With Data Press Coverage 提升医药研发效率,从数据出发 This article discusses the growing volume of raw data collected during clinical research, and how…Certara2025 年 6 月 25 日
Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis On-Demand Webinar 革新传统 NCA 流程:ADNCA 技术助力合规化药代动力学分析 Certara2025 年 6 月 11 日
Using SDTM Data to Produce Patient Narratives Blog 利用 SDTM 数据生成患者叙述 In this blog, we look at how medical writers can use SDTM data produced by…Certara2025 年 4 月 15 日
Exploring Common CDISC ADaM Conformance Findings Blog Exploring Common CDISC ADaM Conformance Findings 2025 年 3 月 27 日 ADaM data are required by the FDA and PMDA and accepted by…Certara2025 年 3 月 27 日
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format Blog FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format 2025 年 3 月 19 日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…Certara2025 年 3 月 19 日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline Blog 滚动提交 NDA 和 BLA:加快审核进度 We look at the growing regulatory trend of rolling NDA and BLA submissions to help…Certara2025 年 2 月 3 日
GlobalSubmit eCTD 4.0 Webinars On-Demand Webinar GlobalSubmit eCTD 4.0 Webinars The world of electronic regulatory submissions is about to change with the introduction of eCTD…Certara2024 年 12 月 3 日
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know Blog CDISC SEND V3.1.1 更新非临床药物开发人员需要了解的内容 2024 年 12 月 3 日 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…Certara2024 年 12 月 3 日
Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemi Poster GalNAc-siRNA 偶联物 Plozasiran(ARO-APOC3)治疗严重高甘油三酯血症患者的群体药代动力学-药效学(K-PD)建模 Certara2024 年 11 月 22 日