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,…

CertaraJune 18, 2020

Blog

How to implement the EPOCH variable

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

CertaraJune 5, 2020

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…

CertaraAugust 22, 2019

Blog

Define.xml frequently asked questions

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

CertaraDecember 10, 2018

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…

CertaraSeptember 27, 2018

Blog

Achieving compliance with the FDA’s eCTD mandate

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance…

CertaraMay 4, 2018

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…

CertaraSeptember 13, 2016

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…

CertaraJuly 25, 2016

Blog

Submitting eCTD in advance of a milestone application

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

CertaraMay 10, 2016

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…

CertaraMarch 14, 2016

Data Standards

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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