Use ALiCE to build an eCTD
The user selects the eCTD template for their region and submission type and then through sophisticated search and browse features (within ALiCE) selects the most appropriate files to populate the eCTD backbone.
The user can navigate the hierarchy and populate or view content, properties, and file status at each level. These files, once identified, are available to use in more than one place in the hierarchy. The eCTD Backbone is saved as an ALiCE file with appropriate security controls, versioning and workflow status. These backbones are available for use in another region or submission type, supporting the re-use of files across applications. Submission readiness analysis examines the files that are populating the eCTD backbone to ensure they are named correctly, in a valid format and that they have reached the correct point in the approval life-cycle. Warnings about empty folders or folders with too many files are highlighted. Filtered views of the submission hierarchy are available by module, discipline and file type, etc.
Submission lifecycle management
(0000, 0001…000n) allows the user to append, replace and delete files that have already been submitted. Adding new files in each subsequent submission allows users to view the cumulative application or each submission sequence.
The ALiCE eCTD manager keeps track of sequence numbers for the eCTD as successive submissions are made. Consequently, the contents of the eCTD can be inspected at any time, giving the user access to the eCTD's entire lifecycle history.
Managing Links
Managing links and document versions within any eCTD process can be challenging. i4i's powerful Link Manager tool places links in PDF file under management when uploaded to ALiCE. Flexibility in this product allows users to update links after publishing, for a particular submission.
eCTD Publisher
Finally, eCTD Manager comes with an additional ALiCE service, eCTD Publisher. This additional service extends the capabilities of ALiCE by providing a Drug Application Submission publishing solution. Upon publication, the eCTD submission content is exported, file checksum values are computed, the backbone, regional and study tagging xml files are generated and the submission is scanned to ensure that it conforms to regulatory requirements and is ready to be submitted.
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