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DMSys is a powerful but easy to use data management system for clinical trials. Our 21 CFR Part 11 compliant software provides all the tools needed to perform data management, from study setup to data export for statistical analysis. Complete with full audit trails, performance metrics, rapid data cleaning facilities, error management, and query management, the system has many practical features to streamline the data management process. Our data dictionary interface allows database structures to be defined and built with zero programming on the user's part. Data entry screen design is a simple drag-and-drop process, using a template screen included with the system. Built-in shortcuts allow study setup files to be copied from a previous study to a new study, or to a new Form within the same study. Excellent security features allow the system administrator to specify each user's access privileges, menu item by menu item, and study by study.

DMSys is extremely flexible. Its rapid study setup facilities make it very cost-effective in small Phase I trials; while its power and speed mean that it just as easily handles large post-marketing studies with tens of thousands of patients. By simplifying the tasks involved in data management, DMSys reduces the resources required and gives its users a significant competitive edge.

These are some of the features that make DMSys easy to use and a great clinical trial solution:

  • A price structure that keeps data management software affordable
  • System fully validated and compliant with FDA and European regulations and GCP guidelines
  • Easy study setup with built-in data checking functions, convenient user interface and minimum programming
  • Easy data entry screen setup with drag and drop data entry screen controls to create your own data entry screens

  • Integrated shortcuts allow you to copy Forms, data entry screens, logic checks and all other study structure from Form to Form in the same study or from one study to another - a major time saver

  • Flexible data entry options
    • Single data entry or double data entry (verification)

    • Data entry in single-form mode (one form for multiple subjects) or cross-form mode (multiple forms for multiple subjects)

    • Interactive or non-interactive verification
  • Interactive range checks at the point of data entry identifying out of range values and interactive second data entry identifying inconsistent values
  • Complete audit trial in compliance with 21 CFR Part 11 including data entry performance metrics
  • High-speed platform provides for rapid data cleaning
  • Error flagging at point of data entry to identify illegible data or other errors for further follow-up or query
  • Sophisticated error management function allowing query generation, error tracking/resolution, and entry of data corrections, including a complete audit trail, from a single screen
  • Robust query management capabilities
    • Allows query generation, tracking and resolution with minimal input from user

    • Numerous options for printing queries, including paper or electronic format, and a customizable Word template that can include your own logo
  • Flexible report writing capabilities with over 30 built-in reports
  • Easy data import from Excel, dBase files and SAS (ASCII) including audit trail, and allows for second data entry to be performed on imported data
  • Easy export to Excel, dBase files and SAS (ASCII) including an option for creating a SAS program that includes input statements and variable labels
  • Excellent security measures to manage access to software functions and study data for each individual user
  • User Validation Package designed to support your validation process
  • High quality and timely training and support services
  • Many more features that make DMSys a great tool... let us perform a demonstration for you. Contact Us

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