Mediolanum Cardio Research

a web-based system for collecting and managing CRF data,
using a standard web browser

  • Main features:

  • Compliance with FDA 21 CFR part 11 requirements and guidelines
    concerning security and data protection.
  • Multi-user and simultaneous data entry.
  • Intuitive friendly web forms.
  • Compatible with Windows / SQL Server and Linux / MySQL and with main browsers
    (Internet Explorer, Mozilla Firefox, Google Chrome, Safari and Opera).
  • Advanced user profiling management and customization.
  • On-line randomization.
  • Source-verified data locking at visit / page / single variable level.
  • On-line control of data plausibility and consistency.
  • Automatic query generation.
  • E-monitoring tools.
  • Double data entry management.
  • Production of blank and annotated CRF.
  • Use of ad hoc medical dictionaries (MedDRA, WHO, etc).
  • Exporting data to SAS and Excel format.
  • Graphic reports and descriptive statistics.

  • Security:

  • Secure data transmission using 256-bit SSL (HTTPS) protocol.
  • Certificate for data encryption acquired from Thawte Certification Authority.
  • User authentication throughout complex personal password.
  • Session timeout after 20 minutes inactivity.
  • Hosting server in a secure web farm under 7x24 monitoring.
  • Redundant hardware.
  • Redundant daily backup.
  • Audit Trail: tracking all user operations (e.g. visited pages);
    user data audit, patients and centres audit, CRF data audit.

  • Screenshot Tour:

  • Main Menu
  • eCRF Data Entry
  • Patients List
  • Patients Data Report
  • Graph Reports
  • Data Audit
  • Audit for all chagnes
  • Blank CRF