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 eCTD Resource Center




WEBINAR: How Standardized Terminology can Accelerate Global Regulatory Performance

June 15, 2022

WEBINAR: Benchmarking Survey - Is EU CTR Driving Tighter Clinical & Regulatory Integration?

March 30, 2022

PRESS RELEASE: Cary Smithson Brings Extensive Life Sciences Regulatory Expertise to Help Phlexglobal Customers Navigate a Transforming Regulatory Landscape

November 11, 2021

CUSTOMER STORY: Treximo Selects Phlexglobal's Innovative Submission Software as Technology Foundation Supporting Strategic Growth in Regulatory Services

March 25, 2021

VIDEO: PhlexSubmission Electronic Common Technical Document (eCTD) Software Introduction


INFOGRAPHIC: Submission Software Decision Guide

March 11, 2021

DATA SHEET: PhlexSubmission (eCTD) Software: Create new or import existing electronic submissions with ease

July 14, 2021

CUSTOMER STORY: Hope Biosciences Stem Cell Research Foundation Selects Phlexglobal to Support Rapid, Compliant New Drug Application for COVID-19 Therapy

November 20, 2020

WHITE PAPER: Industry Survey Results & Expert Analysis

October 29, 2020

VIDEO: PhlexSubmission eCTD Video Demonstration


WEBINAR: Innovation Tour Survey Results Panel: Future Trends in TMF, IDMP, and eCTD

May 30, 2021

ARTICLE: Prepare yourself for 2020 – Global regulatory update

December 6, 2019

ARTICLE: Common Promotional Submissions in eCTD Errors and How to Avoid Them

May 28, 2019

ARTICLE: Phlexglobal’s View on eCTD v4.0

October 30, 2018

ARTICLE: Australian regional specification – eCTD Version 3.1

June 14, 2020

ARTICLE: eCTD Health Canada – an Overview

November 28, 2018

ARTICLE: eCTD Brief: The Deep Dive into Electronic Submissions

November 1, 2017

ARTICLE: FDA has published a new guidance on eCTD 4.0

October 5, 2017

ARTICLE: ICH’s Value to Regulatory

August 11, 2017

ARTICLE: eCTD in the Cloud – Risk-Benefit Analysis

February 24, 2015


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Entering the Post-Paper Realism: The Principles of Cyber Ethics

The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618

Overcoming TMF misfiles and metadata errors to reduce inspection risk

Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled.   In some ways, misfiles are an even greater issue now with eTMF systems, where filing is

TMF Management in Clinical Trials Blog 3: Running the Trial in Your eTMF

Introduction Well, first and foremost, welcome!   Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those

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