Create and Assemble eCTDs

eCTDXPress makes creating eCTDs easy through step-by-step wizards that take you through the entire process. You’ll build STFs by dragging files, add and modify hyperlinks quickly, and compile, validate and verify submissions that adhere to regional and ICH specifications. eCTDXPress lets you build eCTDs easily and confidently.

Configurable Web-based Interface
Customize your workspace for greater efficiency and focus. The web-based interface features an intuitive work area that you can configure to fit specific tasks as they change. Create separate work areas for submission assembly, file exploration, or for adding hyperlinks and document review. Whatever you need to do, there’s a customizable workspace just for you. In addition, you’ll benefit from increased communication as you collaborate with team members from anywhere – whether it’s in the same office or across the world.

Guidance-Compliant Wizards
eCTDXPress makes it easy to create eCTDs for compliance with multi-region support and wizards. Easy-to-use wizards guide you through applications while automatically adding metadata for the appropriate DTDs. Metadata for drop-down lists can be preset and stored in a database for users to share and select information (substance, manufacturer, dosage forms, strengths, etc.) when needed. Wizards also provide support for EU, US, JP and CA regions while all metadata and technical information is handled conveniently in the background. Achieving compliance for all your eCTDs has never been easier.

Adding Files Made Easy
Adding files to your eCTD is a snap with drag-and-drop. Add files from anywhere - whether it’s from a file share, local computer or DMS. With advanced features such as folder mapping, you can automatically move study report files to the appropriate study folders. In addition, you can map DMS attributes to eCTDXPress, automatically tagging study files and adding them to STFs once files are dropped into the submission.