Blog Flex Databases
📅 September 24 | 3 PM CET🎥 Beyond the Binder: Inspection Readiness in the eTMF Era👉 Register here: https://lnkd.in/dnbpUKYY Being inspection-ready is not just about having 100% full eTMFIt’s about knowing what happens before, during AND after an inspection. On September 24 at 3 PM CET, we’re bringing together two experienced clinical research professionals: 🎙️ […]
Flex Databases team is looking for a DevOps/Infrastructure Engineer who can approach infrastructure with intelligence and pragmatism.We have operational systems, mission-critical services, and a ton of interesting challenges. What we’re looking for: • 3+ years of hands-on experience in infrastructure administration, DevOps, or a similar technical role.• Strong practical experience with Windows and/or Linux server […]
Every pharmacovigilance case tells an evolving story. A case rarely arrives once and stays static – new information keeps surfacing after the initial intake: a patient is hospitalized, a birth date gets corrected, a new reaction is reported, a concomitant medication comes to light. For safety teams processing cases from clinical trials, marketed-drug consumer reports, […]
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 […]
