Datafarm, Inc.

S-Cubed^® Publisher

The Complete eSubmissions Paper Dossier Printing Solution

Agency acceptance of eSubmissions

Not all agencies are ready to accept electronic submissions and many expect your applications to be delivered on paper. This can be a significant overhead for organizations that want to leverage the benefits of eSubmissions but do not want to compromise their eSubmission strategy or processes to accommodate paper dossiers.

Printing Paper Dossiers Made Easy

Datafarm is a leading electronic submissions assembly and validation solutions provider and understands the global requirements from all regulatory agencies. We recognize that not all agencies currently accept electronic submissions as a sanctioned document and continue to require paper as an official submission format due to various legal and regulatory requirements.

S-Cubed^® Publisher is designed to address this business requirement. This web-based application enables users to produce paper dossiers from electronic dossiers that include both eCTD and Non eCTD (NeES) formats. The creation of printer-ready paper volumes is provided through a simple, intuitive, multi-agency compliant, web-based application and includes the following capabilities:

produce a paper dossier (pDossier) from an eCTD submission
produce a Hybrid eDossier from an eCTD submission
produce a pDossier from a NeES submission

Compliant Paper Dossiers

The S-Cubed^® Publisher application helps you generate print-ready output from your eCTD or NeES formats. Processing from an eCTD or NeES format enables you to retain your electronic submissions process and the benefits associated with eSubmissions while being proficient in delivering a paper dossier from a single source. S-Cubed^® Publisher delivers significant benefits to your organization by allowing you to create one eSubmission format that can be delivered in multiple formats - electronic and/or paper. Preparing your submissions in an electronic format today offers many cost efficiencies, and when those agencies currently requiring paper are ready to accept electronic submissions, you can take advantage by being prepared for both.

Functional Benefits

S-Cubed^® Publisher is a simple, easy-to-use and multi-agency compliant application that can quickly deliver considerable benefits. Some of those benefits are:

Features	Benefits
Create paper dossiers from existing eSubmissions (eCTD or NeES)	Allows you to reuse existing eSubmission formats – once you have your eSubmission created, you can produce paper volumes as many times as needed
Automated pagination & volumization	Increases accuracy and compliance and saves significant time in manual effort
Automatically creates your table of contents at the module, volume and dossier level	Fast, efficient and reliable creation to ensure your table of contents are created accurately and to the agency specifications
Publishing templates can be created and saved	Create once, re-use many times to increase resource productivity
View changes online	Changes can be applied and immediately available for review/approval, reducing time-consuming rework
Paper dossier visualization	View and approve the compiled dossier in its entirety so that errors and inconsistencies can be eliminated before the paper is produced

S-Cubed^®Publisher is an all encompassing eSubmission & NeES application that provides the following functions:

Create print-ready paper volumes
Create custom pDossier settings for future use
View changes to volumes as they are implemented
View a representation of the pDossier at all levels, from each volume to an individual page
Create TOCs for volumes, modules and submission
Add user-defined headers/footers
Add user-defined watermark
Paginate volume and/or documents
Add and customize tab pages/slip sheets/cover pages
Create job tickets for Docutech™ and other high-speed printers
PDF and PostScript output support with job tickets
Compatible for parallel integration with document management systems such as Documentum and file share

S-Cubed^® Publisher will eliminate the immense time and costs associated with manually reformatting, recompiling and additional QC effort. Coupled with Datafarm’s suite of products, all of your PDF rendering and preparation, eCTD and non-eCTD submissions, report-level and ad hoc publishing requirements will be met.