S-Cubed

A complete eSubmission solution offering comprehensive publishing, compilation, review, validation and printing capabilities.

S-Cubed integrated modules include:

S-Cubed eCTD

S-Cubed® eCTD conforms to the current ICH and regional requirements for delivering eCTD submissions to the US, EU, Canada, Japan, and Taiwan regulatory agencies. Using S-Cubed® eCTD, you can be assured of a software system that includes all of the latest agency requirements so that you can quickly create consistent and compliant eCTD submissions. For more info about S-Cubed eCTD, click here.

S-Cubed NeES/RPL

S-Cubed® NeES enables you to produce any type of PDF-based electronic submission. Submissions are created without the XML backbone, and a PDF table of contents is produced for navigation of the submission content. With customisable templates, you can design your submission structure from scratch or modify one of the supplied templates. You can further produce additional formats, such as aCTD, using the supplied aCTD template. For more information about S-Cubed NeES, click here.

S-Cubed® Publisher

S-Cubed® Publisher, available for deployment as a stand-alone application, addresses this business requirement by enabling you 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 interface. For more information about S-Cubed Publisher, click here.

S-Cubed® CRT

As a certified CDISC solution provider, Datafarm offers S-Cubed® CRT as the answer to a complete solution that automatically creates the entire CRT section of an electronic submission along with the define.pdf and/or define.xml files, SAS transport files and table of contents files, including all of the necessary links and bookmarks. Datafarm designed S-Cubed CRT according to the Case Report Tabulation Data Definition Specification (CRT-DDS) developed by CDISC define.xml team. For more information about S-Cubed CRT, click here.

S-Cubed® Templates

Designed by experienced regulatory professionals, our easy-to-use document templates reduce the time manual formatting requires, allowing you to create consistent, industry compliant documents without the need for extensive in-house training. For more information about S-Cubed Templates, click here.