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
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
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
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
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
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
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
