ICSR Reporting

Flex Databases combines deep clinical expertise with advanced technology to deliver a smarter approach to trial oversight. Our Risk-Based Monitoring (RBM) framework helps sponsors and CROs focus on what matters most, reduce effort and cost, and make faster, data-driven decisions – supported by Flex Databases’ EDC, central/remote monitoring, and AI analytics.  Why Risk-Based Monitoring?  How […]

📑 Tracking regulatory submissions shouldn’t require endless spreadsheets.But for many PV teams, managing ICSR reporting across agencies means manual tracking, external task lists, and risk of missed deadlines. With Flex Databases’ improved Pharmacovigilance Submissions Tracker, everything is now in one place: ✔ Define flexible submission rules by drug, project, and conditions✔ Configure statuses to match […]

Managing monitoring activities often means juggling multiple people, documents, and communication channels. Without the right tools, discussions about data discrepancies get lost in emails or chats, review cycles are disrupted, and KPIs are affected by unnecessary report declines. To solve these pains, CRAAM introduces a dedicated Query feature – designed to make handling data issues […]

Cross-site budget setup can turn into hours of manual per-subject cost entry, slowing teams down and creating error risks. With Flex Databases’ Subject Tracking & Invoicing, you can now import Per Subject Costs directly from Excel using the Data Import Wizard. ✔ Speed up site budget setup✔ Reduce manual entry and errors✔ Import across projects […]