S-Cubed^® eCTD conforms to the current ICH and Regional requirements for delivering eCTD submissions to 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. S-Cubed^® eCTD extends your capability to control access to the submissions through role-based security features and fully manage the submission life cycle by planning and identifying forthcoming sequences. S-Cubed^® eCTD provides you with extensive validation features to ensure that all of your submissions are agency-ready in the most effective, efficient and timely manner possible.

S-Cubed^® eCTD - In Depth

S-Cubed^® eCTD is based on a simple and flexible process model that offers intuitive solutions to diverse business needs at each process level, increasing efficiency and reducing preparation time. Designed to meet your functional needs, S-Cubed^® eCTD applies intelligent and automated business logic to make it easy for you to:

Publish:

• PDF rendition from various source formats (e.g., MS Word)
• PDF publishing - bookmarking, hypertext linking, etc.

Compile:

• Populate submission-ready documents into a submission structure
• Manage the document life cycle
• Perform post compilation PDF publishing tasks
• DMS connectors to access documents stored in the document management systems

Review:

• Review content
• Review eCTD technical requirements

Validate:

• Verify the submission conformance based on ICH and regional specifications

Track:

• Manage the submission life cycle
• Track submission activity after it is submitted

S-Cubed^® eCTD delivers an immediate return on investment, reduces your time to market and can be implemented quickly and easily.

S-Cubed^® eCTD - Technical Superiority, Practical Usability

Supporting multiple standards and formats such as eCTD, RPS and others, and with multi-language support, including all English language dialects and Japanese, S-Cubed^® eCTD requires a minimal number of specialized tools (such as a database and Web server), thus allowing you to leverage your existing systems.