Document management & storage is rarely considered as something complicated, however, it’s a backbone for everything. When it’s done wrong, you’ll experience process delays, incomplete or missing documents, and other data integrity & completeness issues. Flex Databases DMS is done exactly right – and here’s a quick overview of manager & user processes, that get […]
Earlier this summer, WSG – Westdeutsche Studiengruppe GmbH selected Flex Databases as a CTMS and eTMF provider. We’ve asked Michael Städele, Director, Business Development & Operations a couple of questions about the new partnership: Over the last years, we are facing an increasing number of trials, employees, and study sites. In addition, more of the […]
As always, DIA 2023 was mostly about the people we meet & talk to, but there is a big second value to it – the talks, the ideas and insights that we get during the conference. Let’s take a look at what’s hot in Boston! We can’t wait to be back in 2024!
We always say that integration of the systems is one of the keys to success. That’s why we pay a lot of attention to API at Flex Databases. Flex Databases has become a member of CRISI – The Clinical Research Interoperability Standards Initiative, developing a comprehensive library of standard APIs. We are proud to be […]
Our BD&Marketing Director Evgenia Michalčuk-Vráblík has recently set down with LifeScience Review reporter to talk about the No-Code approach that Flex Databases is leading in CTMS world and how it benefits our client’s business operations. The interview followed the reward that Flex Databases received as one of Top-10 CTMS providers in 2023. While maintaining compliance, […]
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 […]
There are some eternal values in regulated companies’ lives: GCP, 21 CFR Part 11, and computerized systems validation. However, even these are subject to change. Recently the most important of them have been updated: And we can add the well-acknowledged guidance to this list: GAMP®5: 2021 Good Practice Guide: Enabling Innovation. The changed regulations do […]
On the first day of June we’ve hosted a joint webinar with our client, Confidence Pharmaceutical Research. Agenda: – Why site payments are an essential part of study management– How the site payment process works at Confidence Pharmaceutical Research/ Lifehacks of Confidence Pharmaceutical Research: how to speed up site payments in real life– More case studies: […]
When working in a regulated industry, learning management is a huge concern since the need to follow SOPs & complete training applies to all company employees (at different levels, but still). It’s complicated enough when we think of dozens of people split between dozens of roles, but what if it comes to hundreds or thousands? […]
As spring continues to bloom, we’re excited to announce our partnership with SOLTI, Spanish academic research group that performs clinical trials of excellence in oncology. With Flex Databases CTMS & eTMF implementation, SOLTI aims to perform detailed analysis based on the information included in the system, have an operational data repository easy to consult and […]
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 […]
Digitalization is complicated not only the first time you go for it, but also when the moment for change comes. When we are a bit too dependant on a software provider, it may seem like there’s no way out, or data migration too much to handle – and it could be a blocker to consider […]
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