eCTD Lifecycle Viewer
Mono eCTD Viewer was built with the ease of use in mind: the complex XML eCTD (Electronic Common Technical Document) structure of an eCTD lifecycle is presented in a user friendly manner.
Mono eCTD Viewer streamlines review process, reduces response times to Agency requests, and ensures faster approvals for your products.
Is your usage scenario covered? [If not, let us know :)]
Sequence / Current / Cumulative?
Mono 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).
Mono eCTD Viewer's user interface is available in multiple languages (English, Dutch, French, German, Spanish, Italian).
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Mono eCTD Viewer Editions
Mono 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 MD5 Fixer, PDF Hyperlink Explorer, Submission Comparer 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!
Advanced PDF keyword search in [sequence/product] folder
Need to find all documents having keyword "study-123"? Need to locate all documents having a link to "responses.pdf" Need to locate all mentions of "Table X" in all your sequence documents? And you need it fast?
No problem! The Advanced Search pane in Document Viewer allows complex in-depth keyword searches - to locate all documents matching the search in a selected [sequence or product] folder and all subfolders.
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: 220.127.116.11 Single dose toxicity (grouped by species and route of administration), 18.104.22.168 Repeat dose toxicity (grouped by species, route of administration, and duration if applicable), 22.214.171.124.1 Long term [carcinogenicity] studies (grouped by species) and 126.96.36.199 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.