Product Updates: December, 2024

December 19, 2024

Product Updates: December, 2024

We are excited to announce several new features and improvements to Flex Databases’ modules. These updates aim to streamline workflows, enhance usability, and improve overall efficiency for our users. Here’s an overview of the latest developments and their benefits.

Trial Master File (TMF)

Duplicates Search: Files Content Comparison

Path: Trial Master File → (open project) → Duplicate Files

Managing potentially duplicate files is now simpler and more efficient. Users can compare the contents of two files in a single view and quickly identify differences.

  • New Option: A “Compare Files” icon is now available under the ‘Actions’ group for each duplicate file with a content match of less than 100%. This feature is accessible to users with TMF Data permissions to view both the source file and the duplicate.
  • Split View:
    • Clicking ‘Compare Files’ opens a split-view interface with the source file on the left and the duplicate on the right.
    • Differences are highlighted with color for easy identification.
    • Users can scroll through both files simultaneously.
    • Navigation icons allow users to jump directly to differences.
    • A full-screen mode toggle is also available for better visibility.

Benefits:

  • Saves time by enabling quick identification of differences between files.
  • Reduces errors and enhances data consistency.
  • Improves user efficiency with a clear and intuitive interface.

Project Management & Budgeting

Budget Import Enhancements

The budget import feature has been extended with additional validation checks to ensure data consistency:

  • Update Restrictions: Prevents changes to the task structure.
  • Field Types: Validates numerical, text, and date fields.
  • Multirole Parent-Child Consistency: Ensures multirole task requirements are met.
  • Available Countries: Verifies that listed countries are added to the project.

The point “Data Replacement Warnings: Alerts users when data is replaced with new values” has been removed as it is described later in the detailed problem notifications.

This structure puts the main part (“Update Restrictions”) at the beginning and merges it with the structure-related check.

These checks aim to prevent inconsistent task structures that could lead to calculation errors. Additionally, the system provides detailed problem notifications in the import log, including line numbers and column names for easy troubleshooting.

Note: Changes in the budget document can impact Units Planning, Final Budget, and Performance Reports, but these dependencies are not checked during the import process.

Benefits:

  • Ensures accuracy and integrity of imported budgets.
  • Minimizes errors and inconsistencies in task structures.
  • Provides clear guidance for resolving issues, improving user confidence.

CRA Activity Management

Module Dashboard Upgrade

A new dashboard has been introduced to the CRA Activity Management module, featuring a default set of widgets:

  • My Pending Monitoring Activities
  • Number of Site Visits: Projection vs Actual
  • Site Visit Reports: Preparation Compliance
  • Site Visit Reports: Approval Compliance
  • Total Number of Deviations per Site
  • Issues Resolution Time

Edit Mode:

  • Users can customize the dashboard layout and add new widgets.
  • Reports built in the Report Tool can be added as widgets.
  • Permissions for widgets mirror the permissions set for corresponding reports.

Benefits:

  • Provides a comprehensive view of CRA activities at a glance.
  • Enhances decision-making with real-time insights.
  • Offers flexibility to tailor dashboards to individual needs.

MSG/EML Viewer

An MSG/EML Viewer has been added to the Trial Master module:

  • Users can open emails uploaded to the module by double-clicking on the document icon.

Auto Uploading Documents (Email Upload)

Users added to the email upload list can now send documents directly to ‘Inbox’ subfolders and create new ones:

  • To upload documents, include the following in the email subject line:
    • project=PROJECT CODE; subfolder=FOLDER NAME

Benefits:

  • Streamlines the process of managing email-based document uploads.
  • Reduces manual effort by automating file organization.
  • Improves efficiency in document handling and accessibility.

These updates reflect our commitment to improving the user experience and providing powerful tools for effective clinical trial management. We encourage you to explore these new features and provide feedback to help us continue enhancing our platform.

Blog

July 7, 2026
Is Your EDC Really Modern If Someone Still Has to Re-Enter Every Serious Adverse Event?

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 […]

June 30, 2026
Validating AI in GxP Environments: The Flex Databases Approach to eTMF Compliance

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 […]

June 25, 2026
The Quiet Revolution in TMF: How AI Document Classification Turns Routine into a Background Task

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 […]

June 24, 2026
Investigator Site File Management with Flex Databases

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 […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.