Blog Flex Databases
FluoGuide lights up cancer to maximize surgical outcomes in oncology and its lead product, FG001, is designed to improve surgical precision. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”. (Q) What clinical trial management challenges led you to seek a new system? Our main challenges were inefficiencies caused by disconnected systems, […]
Most sponsors associate protocol deviations with events that occur later in a clinical trial, like missed visits or incomplete documentation. In reality, one of the earliest and most consequential protocol deviations is happening during patient randomization. Randomization is often perceived as a simple operational step:patient enrolled, button clicked, treatment assigned. But under the pressure of […]
What Sponsors Should Really Look For When Choosing an eClinical Platform? Today, every established vendor offers all kinds of system modules, document management capabilities, and a long list of compliance certifications. On paper, they appear remarkably similar, making it increasingly difficult for sponsors and CROs to distinguish between solutions based on feature lists alone. In reality, they couldn’t be more different. Most enterprise eClinical platforms can […]
Every clinical trial role requires different information. CRAs need to track upcoming monitoring visits, Project Managers need study performance metrics, and clinical operations teams need enrollment and site activity data. In this video, see how Flex Databases CTMS allows every user to create a personalized dashboard without affecting other users. Learn how to add or […]
About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization conducting multi-country clinical trials and supporting post-marketing needs across a growing sponsor portfolio. As case volumes increased, so did the complexity of managing pharmacovigilance activities from safety event intake and workflow tracking to regulatory reporting and cross-functional coordination with clinical operations teams. […]
Clinical industry has finally embraced AI, sponsors run decentralized trials and data is now collected in real time. But still one of the most critical workflows in every study – handling adverse events (AEs) – surprisingly depends on copy-paste. Most sponsors assume that if they have an Electronic Data Capture (EDC) system and a Pharmacovigilance […]
The pharmaceutical industry faces a familiar paradox: the tools that promise to make regulatory compliance faster and smarter also introduce the most complex new compliance questions. Nowhere is this more visible than in AI-powered Trial Master File (TMF) management. At Flex Databases, we have developed a validation framework rooted in GxP principles, risk-based thinking, and […]
AI in Trial Master File management has quietly stopped being a someday idea. It’s not a pilot and it’s not a roadmap promise – it’s something clinical teams reach for on an ordinary Tuesday. The interesting part isn’t that AI can file a document; it’s how calmly and predictably it does it now – with […]
Managing Investigator Site Files across multiple sites is one of the more operationally demanding aspects of clinical trial oversight. Flex Databases addresses this with a dedicated ISF module built around three distinct user experiences (Sponsor, CRA, and Site) each tailored to the workflows and priorities of its audience. The Sponsor View: Study-Wide Visibility Sponsors access […]
When evaluating core clinical research platforms, most companies naturally start with the well-known enterprise brands. They are recognizable, widely adopted, and often positioned as the “safe choice” for regulated environments. But once the demo phase is over and implementation actually begins, many teams discover that choosing a platform involves much more than brand recognition and […]
Vendor oversight has always been part of clinical trial compliance, but ICH E6(R3) has significantly raised expectations for sponsors and technology vendors alike. The updated guideline makes one thing very clear: sponsors remain fully responsible for trial quality, patient safety, and data integrity — even when activities are outsourced to external vendors. This includes ensuring […]
We are looking for seasoned Senior Project Manager who is ready to take full ownership of high-impact projects. At our core, we value delivery over slides and results over rigid hierarchy. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well […]
