Flex Databases Product Updates: Enhanced TMF, PV, and More
May 29, 2025
We’re excited to announce a series of updates across several modules of Flex Databases. From enhanced UI navigation to smarter automation and configuration options, these improvements are designed to streamline workflows and boost productivity across clinical operations.
Trial Master File (TMF)
Redesigned Project Configuration Interface
We’ve introduced a UX/UI enhancement to the Project Configuration section (Trial Master File → Project Settings → Project Configuration). The previously consolidated “Additional” tab has now been reorganized into five intuitive tabs:
- General: Electronic Signature, OCR Configuration, Duplicate Search, File Relation
- Workflow: Flexible Workflow toggle, Expected Documents settings
- Emailing: Email upload options, notifications, sender setup
- Quality Review: Review setup and query management
- AI: AI Auto-classification Assistant
This update ensures easier navigation and a cleaner configuration experience.
Linked Files Restriction Option
To support better project-level control, we’ve added a checkbox option to restrict file links and relations within the same project. When enabled, cross-project linking is disabled, promoting structured project data management.
Subject Tracking & Invoicing | Invoice Template Downloads
A new feature in System Settings → Subject Tracking and Invoicing → Templates allows users to download invoice templates directly to their computer. This helps with offline editing and simplifies transferring templates between environments.
CRA Activity Management | Site Staff Training Log Enhancements
We’ve added two new fields: Activity # and Site # to the Site Staff Training Log tracker. This allows for clearer data association with specific sites and activities, and enables filtering. These fields can be configured via CRAAM > [Project] > Trackers Management.
Pharmacovigilance (PV) | New Case Classification Logic
A new Case Class field has been added to Case Report Card. This editable field is auto-populated based on the most serious event/reaction reported, following a clear hierarchy:
- SUSAR
- SAR
- SAE
- AR or ADR (dependent on Case Type)
- AE
- Other
If the system is configured to exclude assessments involving concomitant drugs, those events will be ignored in classification. Additionally, this field is now available as a data source in the Report Tool under Table: Case Summary → Field: Case Class.
These updates reflect our commitment to continuously improve user experience, efficiency, and regulatory compliance. If you have questions about any of the new features, don’t hesitate to reach out to your Flex Databases contact or support team.
