Pharmacovigilance (PV) is a critical aspect of drug safety, focusing on detecting, assessing, understanding, and preventing adverse drug reactions or other drug-related problems. As global regulatory requirements for drug safety evolve, adopting reliable pharmacovigilance software has become essential for ensuring compliance and improving operational efficiency. Selecting the right PV software can significantly impact your organization’s […]
If you operate globally, you must comply with local language requirements, which also apply to pharmacovigilance reporting. Imagine that you must manage cases & report in English, Spanish, and French. How would you do that? The apparent answer many providers usually offer is multiple inputs of the same cases. Drop that! With Flex Databases Pharmacovigilance, […]
There are three big questions in any industry, including pharmaceuticals & clinical trials: Artificial intelligence is one of the new answers to all of them. Here are a few examples: When it comes to saving time, AI is here to take over data processing – fishing for answers to most minor questions in huge data […]
This September, Pharma Tech Outlook included Flex Databases in Top-10 Pharmacovigilance solutions providers in the UK & Europe. Our Business Development & Marketing Director Evgenia Mikhalchuk took part in a cover story for Pharma Tech Outlook September’22 issue, supporting our nomination: Clinical trials have always been about data. But, prior to automation, data input was […]
Each step of Flex Databases is always done with one thought in mind – to save time and money for our clients. That’s why to save your time and give you a deeper understanding of how our Pharmacovigilance module work, we are happy to answer the six most frequently asked questions about the system. How […]
Many years since the appearance of different platforms and systems for clinical trial operations, there has been a question about making all the systems work synchronized. For most parts of the platforms and systems, it occasionally became possible, though Drug Safety Specialists still have to lead their pharmacovigilance processes independently. Having the objective to streamline […]
The development of information technology is significantly ahead of the development of regulatory and other legislation. Despite the obvious benefits of introducing new technologies in electronic systems for pharmacovigilance, it is necessary to consider the difficulties that a company will face: Validation and audits completion Personal data management Personnel training, possible changes in the organizational […]
As we briefly discussed in the previous chapter, Artificial Intelligence (AI) is used to simulate the processes of a human brain with the help of computer systems. It encompasses various technologies, including rule-following, reasoning – using rules to reach rough or specific conclusions, learning, and self-correction. Implementation areas of AI In the area of pharmacovigilance […]
At the very end of winter, Flex Databases signed a contract for CTMS and Pharmacovigilance module implementation with Italian Human & Digital CRO Exom Group. We’ve asked Luigi Visani, MD, President & CEO at Exom Group a couple of questions about the upcoming partnership: Why did Exom Group decide to pick Flex Databases as a provider? “Since its inception, […]
In 2021 the United Kingdom is moving to its post-Brexit life with new processes, procedures, and laws everywhere, including clinical trials and pharmacovigilance. This piece we dedicate to a simple question – how to move to post-Brexit pharmacovigilance effortlessly and efficiently. All information in this article is based on Updated guidance on pharmacovigilance procedures published by Medicines […]
United States-based Tranquil Clinical Research recently signed Flex Databases as a software provider for Clinical Trial Management System and Pharmacovigilance management solution. Tranquil’s ultimate goal is excellence in the clinical trial process and bringing trustworthy products to patients. Flex Databases CTMS and Pharmacovigilance system are well-known as unified yet flexible eClinical platform for full-cycle clinical trial management. Baseline implementation takes […]
Flex Databases Signal Management tool in Pharmacovigilance module utilizes modern qualitative and quantitative (statistical, machine learning, neural network) methods to detect signals more precisely. And, from now on, it is provided for free for all Pharmacovigilance module buyers. Request a demo via the button on top of the page to know more!
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