Electronic submissions, which used to be optional, are now becoming a requirement around the world. With regulatory agencies embracing standards defined by ICH, HL7 and other organisations, it’s vital to keep up with these standards and identity the most efficient way to produce eSubmissions for your company.
You need a solution that will pay for itself; something that will save time and be introduced quickly and easily, but that you can trust to be accurate and flexible enough to meet the needs of your business now and in the future.
That’s where S-Cubed® from Datafarm can help you.
WHAT S-Cubed® CAN DO FOR YOU
S-Cubed® stands for Smart Submission Solutions and is a collection of individual software modules integrated to provide a complete e-submission system offering comprehensive publishing, compilation, review and printing capabilities.
It conforms to all current ICH and US, EMEA, Canadian, Taiwanese and Japanese requirements, as stipulated in eCTD guidelines and specifications, and includes capabilities to support non-eCTD format standards. S-Cubed® is capable of supporting future (RPS) submission standards when they become available, and with role-based security and submission management, you are in complete control at each stage of the process and can restrict access as appropriate.
Our S-Cubed® system also provides you with extensive validation features to ensure that all your submissions are agency-ready in the most effective, efficient and timely manner possible.
S-Cubed® IN DEPTH
Based on a simple and flexible process model, S-Cubed® offers intuitive solutions to diverse business needs at each process level, increasing efficiency and reducing preparation time.
S-Cubed® focuses on functional area requirements and applies intelligent and automated business logic to make it easy for you to:
- Publish:
PDF rendition from various source formats e.g. MSWord
PDF publishing, including bookmarking, hypertext linking, etc. - Compile:
Populate submission ready document into submission using submission TOC
Manage document life cycle
Perform post compilation PDF publishing tasks - Review:
Review content
Review eCTD technical requirements - Validate:
Verify the submission conformance based on ICH and regional specifications - Print:
Produce agency specific paper volume when required - Track:
Manage your submission life cycle
Track submission activity after it is submitted
The powerful S-Cubed® Submission Manager module gives you the capability to:
- Customise how applications are grouped for easy searching
- Search applications and submissions by one or more metadata value and/or keyword
- Search content text
- View the status (locked / unlocked / submitted) of a submission
- Track agency correspondence
- Manage and reuse application / submission metadata
S-Cubed®: 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® requires no specialised tools, thus allowing you to leverage your existing systems.
- Smart Client
C#.NET
Zero impact client installation
Powerful features, intuitive and easy to use - Browser Client
eCTD View/Review functions
Internet Explorer/FireFox - Server
JAVA
AXISWeb Service Engine
Application Servers; Tomcat, WebLogic, etc. - Database
Oracle, mySQL and others - Document Management
Documentum
QUMAS QDoc
Master Control
DATAFARM AND S-Cubed®, TOGETHER WE TAKE ALL THE STRESS OUT OF eSUBMISSIONS
At Datafarm, we won’t just sell you software; we will work in partnership with you to create the optimum solution for your own specific situation.
With our S-Cubed® eSubmission system you can either utilise all the modules for a totally integrated solution or select only the modules that you need to maximise the performance of your existing software systems.
Whichever route you choose, S-Cubed® will help ensure that your eSubmissions are totally compliant in the most efficient and cost effective manner possible.
