Blog Flex Databases

April 28, 2024

eTMF FAQ – Frequently Asked Questions

An eTMF, or electronic Trial Master File , is a secure system used to manage all the essential documents and data for a clinical trial. It acts like a central library for everything related to the trial, from study protocols to investigator brochures.

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January 25, 2024

TMF Quality Review 2.0

Periodic TMF reviews automatically documented. Quality and completeness under control! Let’s address an intriguing issue in the clinical trial landscape.

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January 18, 2024

Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases

Good Clinical Practice guidelines require clinical trial documents to be kept for at least two years after the last marketing application approval in an ICH region. These documents may need to be stored longer if regulations or the sponsor require it.

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June 14, 2023

RWE-ready eTMF for 24/7 transparency in your documents

As we all know, the eTMF structure for RWE studies differs from a general TMF Reference Model.

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May 19, 2023

5 examples of data sets that are shared between Flex Databases CTMS & eTMF

A study published in the Journal of Medical Systems found that integrating eTMF and CTMS systems resulted in a 50% reduction in the time required to identify missing documents and a 75% reduction in the time required to resolve missing document issues.

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September 15, 2022

How to set up eTMF quality checks in three simple steps

The difference between a paper Trial Master File and an electronic one is not only the storage and availability of documents. eTMF allows you to stay on top of your documentation in terms of quality – and here’s an instruction on how to set up Quality Checks in Flex Databases eTMF.

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September 14, 2022

How to adjust eTMF to your processes in 4 simple steps using flexible workflow

New software implementation is an imminent part of any digitalisation, but it does not come easy: out-of-the-box solutions are usually built with an average consumer in mind.

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May 20, 2022

Data integrity assessment according to ALCOA++: Flex Databases eTMF is fully compliant

Data integrity has always been a critical point during the development of eTMF systems. One of the industry’s latest standards is ALCOA++, and our eTMF module is 100% compliant with ALCOA++.

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January 13, 2022

How to never miss a thing about your eTMF documents

Have you ever missed a last-minute change in the file you’re working with? Do you lose track of thousands of messaging apps and emails? Do document review bugs you by being distributed into many channels, that you must align together?

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November 1, 2021

CTMS & eTMF implementation – Flex Databases & FGK CRO case study

In this video, we’ll tell you about Flex Databases CTMS & eTMF implementation for FGK CRO. We’ve reviewed the case study before, you can find the text version here .

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