As an EDC Data Solution Specialist (Data Manager), you will work at the intersection of data, systems, and clinical research. You will translate clinical study requirements into practical EDC solutions – from understanding study protocols to building and testing electronic forms, configuring validation rules, and supporting clinical data throughout the study lifecycle. We are looking […]
About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization (CRO) specializing in multi-country clinical trials. As ITS expanded its sponsor portfolio and study volumes, it demanded a document management infrastructure capable of keeping pace – one that could ensure regulatory compliance, support sponsor oversight, and maintain operational control across a growing […]
Every month, Flex Databases ships updates driven by real friction our clients run into on active studies. July’s release focuses on one theme in particular: removing manual, repetitive work that takes up study teams’ time and creates avoidable errors. From protecting critical configurations to automating bulk data entry and site-specific workflows, these updates address everyday […]
How Flex Databases gives Sponsors more flexibility without compromising compliance by building eCRFs from scratch, in-house, for every client. Let’s face the facts: not every EDC provider actually builds the technology behind the study. When it comes to the eCRFs, many rely on third-party solutions. And while they still position their EDC as the best […]
📅 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. […]
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