Blog Flex Databases

We are excited to announce several new features and improvements to Flex Databases’ modules. These updates aim to streamline workflows, enhance usability, and improve overall efficiency for our users. Here’s an overview of the latest developments and their benefits. Trial Master File (TMF) Duplicates Search: Files Content Comparison Path: Trial Master File → (open project) […]

Clinical trials are becoming more complex every year, and sponsors are raising the bar for what they expect from sites. They want faster processes, more accurate data, and better ways to keep patients engaged – all while staying compliant with ever-evolving regulations. As we look ahead to 2025, these demands will only grow. New technologies […]

We’re pleased to announce that Flex Databases’ IT security measures are now formally certified under ISO 27001. This certification, earned after a thorough audit, demonstrates that our systems meet internationally recognized standards for information security. ISO 27001 sets requirements for managing sensitive company and customer data securely. By achieving this milestone, we assure our clients […]

The Trial Master File (TMF) is the cornerstone of clinical trial documentation, serving as the definitive record of compliance with regulatory standards and ethical guidelines. Yet, the management of TMFs has grown increasingly complex with the rise in document volume, diversity, and stringent compliance requirements. Artificial intelligence (AI) is poised to address these challenges, introducing […]

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 […]

Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems are critical to the effective management of clinical trials. By integrating CTMS and EDC, organizations can streamline processes, enhance data quality, and improve overall efficiency. Here are five key tips to ensure a successful CTMS and EDC integration. Effortless Integration of Flex Databases CTMS […]

A new round of our traditional meetings took place in October. This time, we gathered our beloved users to discuss the use of eTMF — from everyday activities to audit preparation. We reviewed how newly released features, such as duplicate search, quality review, and metadata notifications, influence TMF workflows. It appeared not everyone was using […]

We’re excited to announce that Flex Databases will be participating in this prestigious event from November 4–6, 2024. Join us to explore our innovative solutions! Connect with Kristina Kojoushko at the event to learn more about our services, including eTMF, CTMS, Pharmacovigilance Software and more. 📅 Schedule a meeting with Kristina at kristina.kojoushko@flexdatabases.com or reach […]

Did you miss our recent webinar on Quality Digitalization? The recording is now available! In this insightful session, Anna Petrovskaya, QA Director at Flex Databases, and Vera Valesova, PhD, Senior Manager at Deloitte, explore the critical aspects of transforming your QMS into a digital solution. Key topics covered: Watch the full webinar and gain valuable […]

October, 2024 – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a strong pipeline of immune modulating antibodies, together with Flex Databases announce the successful implementation of Flex Databases’ Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions, including a new AI-driven feature for automated document filing and metadata assignment. This partnership […]

In October 2024, the U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. https://www.fda.gov/media/166215/download    This guidance provides recommendations on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product, and new animal drug clinical investigations.  […]

We had the pleasure of sitting down with Martin Krauss, Co-Founder and Managing Director of FGK CRO, to discuss how Flex Databases has supported their clinical research operations over the past 3.5 years.In this interview, Martin shares: • Why FGK CRO initially chose to partner with Flex Databases.• How our CTMS, TMF, and LMS solutions have transformed […]