Publishing System

OmniFILE™

One Integrated Solution: Intuitive Electronic Submission Compiler

Intuitive software that electronically publishes compliant documents, reports, protocols, INDs, eCTDs, eBLAs, eNDAs, 510ks, PMAs, Amendments and Supplements for US and EU regulatory agency review.

Dynamic Publication Templates

  • Pre-defined dynamic electronic report and submission publication templates.

Intuitive Graphical User Interface

  • Drag and drop source files into report and submission structures
  • Add, delete, move, promote, and demote files and folders.
  • Insert and save placeholders for future use.

Extensive MS Word and Acrobat Enhancements

  • Automated bookmark and hyperlink creation based on key word search and TOC content.
  • Build internal and cross-document MS Word-editable TOCs.

Smart Header and Footer Master Templates

  • Create and manage smart header and footer templates containing document, report, volume, and submission attributes.
  • Choose custom pagination schema and document attributes and automatically resolve all fields during the rendition and compilation process.

Optimized PDF Rendering

  • Select various options for PDF rendering of source documents.
  • Generate PDF bookmarks based on MS Word styles.
  • Mask headers and footers.
  • Resolve smart bookmarks and hyperlinks.
  • Create a flexible pagination schema.

eCTD Publishing

  • Build and manage eCTDs using the pre-defined dynamic eCTD publication template.
  • Import your own existing eCTD publications from a file repository.
  • Perform DTD validation, and automatically generate Module TOCs, eCTD, M1, and study tagging file indices.

OmniFILE™ Features

  • Enhanced Word and Acrobat bookmark and hyperlink manipulation tools.
  • Pre-defined, dynamic, electronic report and submission publication templates for compiling compliant reports, protocols, INDs, eCTDs, eBLAs, eNDAs, 510ks, PMAs, Amendments and Supplements.
  • Drag-and-drop editing of report and submission publication templates.
  • Optimized batch PDF rendering and compilation.
  • Set header and footer templates, TOC options, navigational bookmarks, document content tags, eCTD file operation, at the file, folder, or submission level.
  • Set header and footer templates, TOC options, navigational bookmarks, document content tags, eCTD file operation, at the file, folder, or submission level.
  • Define or automatically populate PDF document information fields using source document properties.
  • Generate multiple TOCs for each volume/module in the report/submission, including the main report/submission index or a comprehensive TOC in various MS Word table styles.
  • Automatically add eCTD folders to build multiple drug substance / manufacturer, drug product, and indication heading elements.
  • Define eCTD heading element and STF attributes.
  • Associate or link study files to the STF such as datasets, program files, variable definition tables, CRFs, and literature references located in folders within as well as outside the study file folder.
  • Automatically correct eCTD file naming non-compliances.
  • Validate files and folders, scan files > 100MB, file names > 64 character in length, and file paths > 255 characters.
  • Validate DTD against eCTD final folder output.
  • Automatically generate flat eCTD XML backbone based on granular Module 4 and Module 5 folder structures.
  • Automatically generate and validate MD5 checksums.
  • Clean up submission, maintain eCTD project structure, automatically delete empty folder and placeholders.

Benefits

  • Automate manual publishing processes.
  • Reduce manpower required for electronic publishing activities.
  • Minimize IT resource implementation demand and ongoing support.
  • Reduce hardware requirements and cost.
  • Effciently reuse documents, reports, and submissions.
  • Enhance productivity.
  • Shorten electronic publishing and overall development timelines.

System Requirements

  • Microsoft Windows 2000, XP
  • Microsoft Windows Server 2000, 2003
  • Microsoft Office 2000, XP, 2003
  • Adobe Acrobat 5.0.5, 6.0, and 7.0

 

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

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