A complete clinical trial management system that tracks and monitors every step of a clinical trial.

 

Ergomed web-based clinical trial management system (CTMS) helps us plan, track and provide oversight of all tasks and activities related to clinical trial set-up, conduct, and closeout.

Using Flex Databases, our CTMS enhances global data quality even with complex trials across multiple sites and countries, by generating a single, centralized source of data.

By tracking all site and trial-related activities, our clinical trial management system can monitor milestones, offers instant visibility on the performance of the trial, and quick identification of developing issues. It provides cross-system integration, sponsor access to data and performance, easy access to data and because it is updated in real-time, all study insights are accurate and up to date.

Our clinical trial management system offers:

  • Smartly structured and easily searchable contact information
  • Role-based project access
  • Site feasibility and qualification, site performance management
  • Centralized regulatory/IRB/LEC submissions, and approval tracking
  • Site visit planning and scheduling, creation of visit-related documents
  • Automated notifications of delays
  • Assessment metrics creation and CRA performance assessment metrics
  • Protocol deviation tracking
  • Participant enrolment log
  • Equipment/inventory log
  • Automated site invoice generation, invoice status tracking
  • Standard reports (Graphs, widgets), business intelligence reporting tool.

eTMF

As part of our CTMS, Ergomed’s eTMF system offers complete inspection readiness by means of automated missing document reports, folder completeness statistics, and a range of notifications.

Our eTMF allows quick setup using Ergomed’s standard filing structure or can be customized to match a sponsor’s eTMF. It combines a high level of security with an easy-to-use experience, offering transparency and visibility on your clinical study documentation.

Our eTMF system also permits external access for approved inspectors, auditors, and partners with little training needed.

Our eTMF offers:

  • Simple TMF template creation, including folders and file placeholders
  • Powerful search engine
  • Batch documents upload and download, with drag and drop function
  • Real-time statistics on TMF completeness
  • Adjustable notifications triggered by content, metadata or status change
  • Business intelligence widgets and reports, dynamic metadata report
  • Ability to configure workflow to your needs