TITLE |
PUBLISHED |
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 |
November 11, 2021 | |
March 25, 2021 | |
VIDEO: PhlexSubmission Electronic Common Technical Document (eCTD) Software Introduction |
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March 11, 2021 | |
July 14, 2021 | |
November 20, 2020 | |
October 29, 2020 | |
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 |
October 30, 2018 | |
ARTICLE: Australian regional specification – eCTD Version 3.1 |
June 14, 2020 |
November 28, 2018 | |
ARTICLE: eCTD Brief: The Deep Dive into Electronic Submissions |
November 1, 2017 |
October 5, 2017 | |
August 11, 2017 | |
February 24, 2015 |
Automation
Outsourcing
TMF
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
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
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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