Authoring Tools

OmniTEMPLATE™

One Integrated Solution: Intelligent Document Creator

Intelligently designed style and content templates that efficiently create report, protocol, SOP, IND, eCTD, eBLA, eNDA, 510k, PMA, Amendment and Supplement documents.

Comprehensive Authoring Package

  • Enhanced style template for formatting documents.
  • Easily manageable content templates.
  • Detailed style guide providing user instructions and best publishing practices.

Flexible Implementation

  • Store on the user’s local hard drive.
  • Store in a secure network location accessible to all authors.
  • Store in Electronic Document Management Systems (EDMS) accessible to authors.
  • Attach to existing MS Word documents for easy updating.

Integration with the OmniFILE™

  • Fully compatible with the OmniFILE™ and other electronic publishing systems.

OmniTEMPLATE™ Features

  • Powerful document wizard that supports creation of multiple CTD sections all at once according to the ICH document granularity requirements.
  • Automatic generation of Report, protocol, SOP, IND, eCTD, eBLA, eNDA, 510k, PMA, Amendment and Supplement documents.
  • Automatic population of header / footer text and fields based on custom attributes and values.
  • Automatic generation of documents using ICH-CTD file naming convention.
  • Automatic population of document information title fields.
  • Custom styles, toolbars, and macros.
  • Auto-generation of TOCs, Lists of Tables, Figures, and Appendices.
  • Automatic table creation and table splitting.
  • Automatic creation of portrait/landscape pages.
  • Automatic portrait-to-landscape or landscape-to-portrait conversion.
  • Automatic conversion of US Letter to A4 paper size.
  • Creation of PDF files with bookmarks extracted by styles.
  • Desktop publishing standards that conform with the FDA and ICH structure and content formats.
  • A comprehensive list of literature reference examples and citing instructions.

Benefits

  • Eliminate common MS Word formatting errors.
  • Easily implement and manage style and content changes.
  • Optimize downstream electronic publishing.
  • Efficiently reuse documents, reports, and submissions.
  • Enhance productivity.
  • Shorten electronic publishing and overall development timelines.

OmniTEMPLATE™ is compatible with Microsoft Windows 2000/XP and Microsoft Office 2000/XP/2003.

 

Click here to request additional information on Omnicia's product offering or send us an email at sales@omniciainc.com.

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