Blog

Mapping considerations for screen failure, not assigned, and not treated subjects

In this blog, we clarify the best practices when mapping data for screen failure, not assigned,…

Certara2020 年 6 月 18 日

Blog

How to implement the EPOCH variable

Implement the EPOCH variable in clinical data efficiently. Get expert tips for accurate derivation, error…

Certara2020 年 6 月 5 日

Blog

Common questions about define-XML and the stylesheet

In this blog, we answer common questions about Define-XML and the Stylesheet, including all you…

Certara2019 年 8 月 22 日

Blog

Define.xml frequently asked questions

Discover answers to common Define.xml FAQs, covering best practices, expert tips, and essential guidance for…

Certara2018 年 12 月 10 日

Blog

FDA’s new ANDA submissions guidance: Key points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…

Certara2018 年 9 月 27 日

Blog

Achieving compliance with the FDA’s eCTD mandate

The US Food and Drug Administration (FDA) has set 2018 年 5 月 5 日 as the compliance…

Certara2018 年 5 月 4 日

Blog

FDA’s new Module 1 is a bridge to eCTD 4

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group…

Certara2016 年 9 月 13 日

Blog

How to prepare a study data standardization plan (SDSP) for FDA

Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…

Certara2016 年 7 月 25 日

Blog

Submitting eCTD in advance of a milestone application

While advanced GPS systems and the advent of Big Data analytics are negating some of…

Certara2016 年 5 月 10 日

Blog

Best practices for placing drug master file reference letters in regulatory applications

Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…

Certara2016 年 3 月 14 日

数据标准

Mapping considerations for screen failure, not assigned, and not treated subjects

How to implement the EPOCH variable

Common questions about define-XML and the stylesheet

Define.xml frequently asked questions

FDA’s new ANDA submissions guidance: Key points

Achieving compliance with the FDA’s eCTD mandate

FDA’s new Module 1 is a bridge to eCTD 4

How to prepare a study data standardization plan (SDSP) for FDA

Submitting eCTD in advance of a milestone application

Best practices for placing drug master file reference letters in regulatory applications

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