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 eCTD Resource Center

 

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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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Clinical Trials & the TMF 101 - Blog 4: The TMF Trinity

Introduction We have been on a journey you and me, we started off by understanding the purpose of a clinical trial and the multiple phases to get products to market. We then looked at the Trial

Clinical Trials & the TMF 101 - Blog 3: Paper vs Electronic, why it is more than a DMS

Introduction Awww it warms my heart you came back to read the third blog. I hope you are finding these helpful, don’t forget to send any of your feedback or questions to rtjones@phlexglobal.com. We

Clinical Trials & the TMF 101 - Blog 2: What is this TMF you speak of?

Introduction You came back, great! I hope you enjoyed our first blog in this series which was all about the basics of a clinical trial. In this blog we are going to get into the Trial Master File,

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