Data Standards Archives

Case Study

Biogen Transforms Study Metadata Management with Certara’s Metadata Repository

Discover how study metadata management, paired with CDISC standards, transformed Biogen’s clinical trial processes and…

Certara2025 年 9 月 5 日

Press Release

Certara Launches Pinnacle 21® Enterprise Plus to Deliver Regulatory Submissions Faster

Pinnacle 21® Enterprise Plus delivers a 50% reduction in time spent drafting mapping specifications, according…

Certara2025 年 9 月 4 日

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

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

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

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

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

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

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

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

数据标准

Biogen Transforms Study Metadata Management with Certara’s Metadata Repository

Certara Launches Pinnacle 21® Enterprise Plus to Deliver Regulatory Submissions Faster

Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus

提升医药研发效率，从数据出发

革新传统 NCA 流程：ADNCA 技术助力合规化药代动力学分析

利用 SDTM 数据生成患者叙述

Exploring Common CDISC ADaM Conformance Findings

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

滚动提交 NDA 和 BLA：加快审核进度

GlobalSubmit eCTD 4.0 Webinars

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