Blog 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. The EU Clinical Trial Regulation (CTR) 536/2014 demands that the content of the clinical […]

As we all know, the eTMF structure for RWE studies differs from a general TMF Reference Model. Here’s the list of main differences: To make everyone’s lives easier, we added a template for RWS to our eTMF – you can select it when you create an eTMF structure for the project from the list of […]

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. Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible […]

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. In Flex Databased eTMF, […]

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. It would tick the necessary and important boxes, but other than that you usually must adjust and shift your processes and procedures to it. At Flex Databases, we […]

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++. Let’s see what advantages it brings to our clients.  A – Attributable   In our eTMF module, all actions conducted with each item are caught, […]

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? It’s not a problem anymore! With eTMF chat in Flex Databases eTMF everything, that you […]

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. Timecodes:00:19 About Flex Databases00:46 VIdeo plan01:00 About FGK CRO01:44 Project Scope02:00 Project timeline: Preparation stage02:30 QA environment02:54 Production delivery03:15 Feedback from the client03:54 Contact us