Start Authoring the Right Way
Medical Writers and Regulatory Affairs Specialists can start authoring the right way by using Datafarm’s S-Cubed® Templates designed with formats based on the Common Technical Document (CTD) Module 1 through Module 5, Investigational New Drug (IND), or the Clinical Trial Application (CTA). Conforming to regulatory guidelines, Datafarm’s S-Cubed® Templates deliver the perfect starting point to write structured, compliant submission content.
Designed by experienced regulatory professionals, easy-to-use S-Cubed® Templates reduce the time manual formatting requires, allowing end-users to create consistent, industry compliant documents without the need for extensive in-house training.
Focus on Content Not Format
Specifically designed for authors, S-Cubed® Templates come with preset heading styles including CTD numbering, tables, guidelines, and instructional notes, allowing end users to focus on the content rather than the formatting.
The S-Cubed® Templates’ customized toolbars support both Microsoft® Word® 2003 and Word® 2007. Complete with Word 2007 ribbon support, heading styles, numbered lists, table formatting, symbols, and many other features, the toolbars enable users to create well formatted documents at the touch of a button. In addition, the toolbars comply with industry guidelines helping ensure users work in accordance with their organization’s standard operating procedures.
Edit Quickly and Efficiently
Changing document properties can be time consuming and can often lead to vital information being invalid or omitted, thus causing serious validation issues. With a single entry into the document properties tool, users can accurately change important information, such as product name, dosage form, and study name, throughout the entire document.
Create a Table of Contents in Seconds
The S-Cubed® Templates’ Table of Contents tool is a simple and efficient way to create consistent formatting in seconds. With the ability to automatically create a table of contents, this feature reduces the manual effort usually required, allowing users more time to ensure the content is correct without having to worry about the formatting.
Creating Tables Has Never Been Easier
Content authors can spend hours editing tables, ensuring that the font size conforms to the ICH standard requirements, without getting the desired results. The S-Cubed® Templates’ Tables Toolbar makes it easy to fill out all aspects of a table, including the header, text, source, and notes. Users simply fill in desired options and build tables with a consistent, compliant format.
Ensuring Formatting Consistency
A major concern to most authoring groups is formatting consistency. The S-Cubed® Templates’ simple-to-use numbering list feature allows users to quickly set numbering styles and ensure that all authors conform to the same numbering sequences.
1. Numbered List
a. Alpha List
• Bulleted List
i. Roman List
Easily Combine Multiple Sources
When creating a single document based on a variety of individually authored components, there can be many different formats that need to be integrated. Datafarm’s S-Cubed® Templates help users easily manage unformatted text from different sources using the “paste unformatted text” function. When importing text from another source into the working document, S-Cubed® Templates adopt the current document’s format. This ensures that all text is formatted consistently so that the document appears to have been written by one author.
When it is This Easy and Effective, Why Choose Anything Else?
S-Cubed® Templates are part of the S-Cubed® suite of software that integrates to provide a complete electronic submission solution. The S-Cubed® suite includes state of the art modules that deliver comprehensive authoring, publishing, compilation, review, printing and complete lifecycle management of the submission throughout the entire drug development process. Datafarm partners with all clients utilizing S-Cubed® and will help ensure that regulatory affairs delivers compliant applications to the global regulatory agencies today and in the future.
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