OmniComm Systems

TrialMaster Archive
Overview \| FDA Submission module

Overview
TrialMaster Archive (TMA) presents your data (post lock) in TrialMaster browser view (tree configuration) delivered to you via CD in read only format with the ability to export to study specific formats. This application does not require any software installation and will grant you and the FDA the ability to review your data by trial, site, patient, visit and form parameters. Formats available are read-only and print-friendly, with and without audit trails. A PDF version of the above data is also available. All completed iCRFs are delivered to you on CD, sorted by site,
subject and visit, in the same configuration as the Browse tab within TrialMaster. The form status icons are displayed, just like the real TrialMaster! The trial sponsor receives a CD with data for all sites, including final data exports in the formats your TrialMaster study used. Each site will receive a CD with just their site data. The program is self-contained, so there is: No software to install to view the CD No minimum (or maximum) requirements No internet connection required! All the site will need when the reviewer comes to call is a computer with a disk drive and their TrialMaster Archive CD.

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