Easy to use & user friendly
eCTD Viewer's user interface is available in multiple languages (English, Dutch, French, German, Spanish, Italian).
eCTD Viewer's fluent user interface hosts a filter pane, a backbone tree (including current, cumulative and custom views) and a set of tabbed panes to quickly preview documents, metadata attributes, envelopes (regional information), lifecycle info, STFs, PDF hyperlinks, etc. Can be easily configured to match your (client) needs.
To load a lifecycle, eCTD sequences (documents and folders) need to be available through the file system (local drive or network shared drives). eCTD Viewer requires no special server components and can be run on any Windows version. Runs on laptops, desktops or server and cloud environments.
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eCTD Viewer Features
Your eCTD Viewing Solution
Even if you already have an eCTD viewing solution - try eCTD Viewer to unleash all the potentials of an eCTD lifecycle!
Using additional tools included, like PDF Hyperlink Explorer, you can understand your e-submissions more deeply.
PDF Hyperlink Explorer
Need to explore all hyperlinks between PDF documents sharing a common folder (like an e-submission, eCTD/NeeS sequence folder)? PDF Hyperlink Explorer quickly scans and processes PDF documents and hyperlinks to present a clean and simple view of how your documents are cross-linked. Check for the type of the hyperlink (including link text, page, position), target documents, whether a document is optimized for Fast Web View, if PDF properties are valid (initial view magnification, initial view page layout, PDF version, etc.). Process any PDF collection - not only an eCTD/NeeS submission!
We believe an eCTD viewer should not only allow you to simply view documents in an electronic submission lifecycle. How about having an option to add custom notes for every document in your electronic submission? How about being able to also mark a document with a "flag" using custom flag names?
eCTD Viewer lets your transform simple viewing into a more two-way experience. Save (and load) multiple notes per one submission. Share your notes with others in your team!
Lots of STFs in your (FDA) eCTD submission?
STF Categories tab will display all your study tagging files grouped using category elements as specified in the STF. This includes: 188.8.131.52 Single dose toxicity (grouped by species and route of administration), 184.108.40.206 Repeat dose toxicity (grouped by species, route of administration, and duration if applicable), 220.127.116.11.1 Long term [carcinogenicity] studies (grouped by species) and 18.104.22.168 Study reports of controlled clinical studies pertinent to the claimed indication (grouped by type of control).
Study View will display documents in a selected STF grouped by their file-tag values.
File reuse / Reference leaves / Virtual documents
The name is not unique but the idea is encouraged by ICH and Agencies: eCTD provides the ability to submit a file once and display it in multiple locations of the eCTD by providing multiple leaf elements referencing that file. File Reuse tab visually displays how your submission documents are reused in a sequence or even across sequences. Reviewers or your product, and you, can readily identify files which are referenced multiple times.
Documents linking to other (same sequence or cross-sequence) documents
You think a study-report.pdf under an M5 section has hyperlinks to a few other documents in the submission? Not sure if this one points to M2 data and if all the hyperlinks are functional? Activate the Hyperlinks tab and find the answers - visually identify targeted documents in the same or across different sequences.
- Current / cumulative / sequence / regulatory activity / custom views.
- Clear presentation of submission metadata, such as indication, dosage form, manufacturer, excipient.
- Visual indicators for lifecycle leaf operations (new, append, replace, delete).
- Metadata attribute viewer.
- Load a document in embedded PDF viewer, external PDF viewer or just locate in Windows Explorer.