FDA Submission & Archive Utility

Through the TrialMaster Submission & Archive Utility, OmniComm can provide the client with an export of all trial data in originally captured format and viewable by trial, site, subject, visit and form.  The data is self-contained on a CD that can be sent to the sponsor and each site that require access to their data post study close-out.  The sponsor casebook is fully tabbed and bookmarked by site and domain for record retention or for submission to the FDA or EMEA.  Three types of TrialMaster clinical study data archives are made available to clients: A Site or Sponsor Archive disc, a Trial Export Archive disc, or an FDA Submission module disc.

TrialMaster Archive Module:

A TrialMaster Archive (TMA) presents the site or sponsor clinical study data, post lock, in TrialMaster browser view tree configuration delivered via CD in human-readable format with the ability to export to study specific formats. This application does not require any software installation and grants the client, the sponsor, and the FDA the ability to review data by trial, site, patient, visit and form parameters. Formats available are read-only and print-friendly, with and without audit trails. All completed iCRFs are delivered in CD, DVD, or BlueRay disc, sorted by site, subject and visit, in the same configuration as the Browse tab within TrialMaster.

A Trial Export Archive provides all study data in file formats suitable to be accessed with statistical analysis software: CSV, TAB, PIPE, SAS, and XML. A CD with compressed files is delivered to the CRO, allowing them to perform multiple types of data analysis.

TrialMaster FDA Submission Module:

The FDA Submission Module creates a Casebook containing PDF formatted copies of all Case Report Forms (CRFs) in FDA submission format.  This Casebook is fully tabbed and bookmarked, by site and domain, making it easy to find and view particular CRFs or information in multiple formats.  The Submission Module is an optional component used in conjunction with OmniComm's TrialMaster Archive Module and it is delivered in CD or DVD format.