Create
navigation-rich, searchable
PDF reports
Discover how you can use DocShifter for
fully automated report level publishing
Create PDF reports to include in
your regulatory submissions
PDF collation for submission documents
Create other non-regulatory PDF reports
PDF collation for other reports
Fully automate all your
report level publishing with
a centralized solution
DocShifter has the ability to generate reports by merging multiple documents into 1 or more health authority compliant PDFs; including cover pages, ToC, ToT or ToF, bookmarking, adding pagination, headers, footers and much more.
Fully automated, with no manual steps involved.
Automate everything your reports need
From creating cover pages, table of contents/tables/figures, merging or splitting documents, pagination, watermarks, headers & footers, DocShifter automates everything for you.
Drastically reduce the risk of non-compliance
Reduce the need for manual tools and steps in your report generation process.
Integrate with your existing systems
Whether your documents reside in folders on your network, in your controlled Document Management Systems, or in other solutions that contain content, DocShifter can connect directly to them via direct or web service modules.
Move away from manual, decentralized methods
Reduce the dependency on manual tools, plug-ins or complex solutions designed for submission compilation.
Save time and money through automation
Ensure consistency in the reports you create by removing manual steps. Once setup, DocShifter will create high-quality, navigation-rich and technically compliant reports.
10x faster PDF conversion with reduced costs
DocShifter doesn't need authoring applications (MS Office, Adobe technology, etc.) to perform document-to-PDF conversion. This speeds up the report creation process, and reduces the required licensing and infrastructure costs.
Free FDA PDF format specifications checklist
To help you out in your submissions to US FDA, we prepared a free checklist. This free FDA PDF specifications checklist can help you reduce risk of non-compliance in your submission content preparation for FDA.
Simplify and speed up
report generation
Specify the contents required
Define the content required for inclusion in your reports in ZIP files, folder structures, Documentum Virtual Documents (VDs), or Veeva binders. The order within the report can also easily be specified regardless of the source.
Automatically merge multiple documents into 1 or more PDFs
Whether you need to create clinical study reports (CSR), standard operating procedures (SOP), training guides, annual reports, or any other type of report, DocShifter can automatically merge multiple documents; add the required table of contents, bookmarks, cover pages, watermarks, consistent header and footers and more.
This reduces the manual burden of having to collate and finalize reports manually.
Automated PDF enrichment and compliance features to accelerate your report creation processes.
Cover Pages
Automatically add cover pages at the beginning or end of your reports. Leverage the metadata in your DMS to include dynamic titles, add visuals such as company logos, graphics or other text, etc. All designed in the tools you already know (MS Word).
Table of Contents
Automatically create an overall table of contents that covers the sections for the entire report.
Table of Tables & Table of Figures
If needed, also include separate Tables of Tables, Tables of Figures, etc.
Merge multiple documents
Merge as few or as many documents together as needed for the report type needed. Whether just a few, or hundreds of documents, DocShifter will merge documents no matter what the original format.
Consistent headers & footers
Automatically add consistent headers and footers to your report. Leverage attributes from your DMS to further automate the process.
Pagination across all documents
Automatically add consistent pagination across your final report.
Split reports into multiple output files
If you need to create the report in multiple output files, DocShifter can automatically split the final report based on page count, or file size.
Hyperlinks & bookmarks
Ensure your hyperlinks and bookmarks continue to function correctly, and are styled appropriately throughout your reports.
Meet all your compliance needs
The final report can meet all the same technical specifications as any individual document rendition created by DocShifter. Optimized for fast web view, correct PDF version, fonts embedded, initial page view settings defined, etc.
Frequently Asked Questions on Automated Report Level Publishing
DocShifter’s automated report level publishing capabilities generate navigation-rich, searchable PDF reports.
For inclusion in regulatory submissions, these reports must comply with the right submission structure. Compiling, publishing and reviewing needs to be done by a publishing tool, like Lorenz Docubridge.
Yes to both questions. DocShifter can automatically create bookmarks in many different ways. DocShifter can create bookmarks from custom heading styles, as well as from Word’s default headings.
For Table of Contents (ToC), you can define whether you would like to create it at Word level, or PDF level. You can set limits, and skip generating a ToC if the page contains less than 5 pages, for example. You can also automatically define rules to automatically create a ToC if the page exceeds 10 pages.
For more questions, please drop us a note.
A clinical study report is an extensive report; including statistical descriptions, presentations and analyses of a clinical study. A CSR usually utilizes tables and figures to present the data.
A CSR provides an overview of how and why the trial was chosen; gives information on the plan; methodology and the conclusion of the study.
A clinical study report’s format and content are defined by ICH. A CSR must contain study objectives, investigational plan, study patients, efficacy and safety evaluations, and overall conclusions.
By ‘fully automated’, we mean that report level publishing doesn’t have to include any manual work. Today; companies use complex publishing tools (typically designed for submission publishing) that require lots of manual configuration to generate reports. And this manual configuration is required for every report.
DocShifter, once configured, will fully automate your report publishing needs. Without any manual intervention, it will merge documents; add ToC, bookmarks, headers and footers; and generate 1 or more PDF outputs.
Yes of course. We thought you were never going to ask.
There are multiple options:
- Hand-held demos with your own content.
- A dedicated environment that you can use to upload files to. Where you can configure your own workflows.
- On-premise trial installations, so you can test quality and performance within your own infrastructure.
Document level publishing is the process of creating bookmarks, hyperlinks and other required PDF elements for the document. The goal of document level publishing is to make navigation easier; and therefore simplifying the review process.
DocShifter has native integrations with OpenText Documentum, Veeva Vault, Microsoft SharePoint Cloud, Generis CARA, Lorenz Docubridge, File Systems, Dropbox and FTP.
It also supports any other system that allows Web Services API connections, such as IBM Filenet, Box, Alfresco, etc.
If your content repository isn’t represented on the Integrations page, please use the Contact Us options to ask. We will be happy to investigate your question.
DocShifter subscription pricing is server, volume and functionality based.
To find out more about pricing, please visit our Pricing page and request a quote.
DocShifter is the world’s fastest any to any conversion software. Speed, quality, scalability and configurability are the reasons why leading companies use our software to convert their documents into high quality, navigation-rich, searchable content.
Compliant, fast, automated and scalable
file format conversion for the regulated enterprise.
PharmaLex reduces manual work, and the associated costs & risks to accelerate compliant PDF conversion of submission content
“DocShifter will save us over 750 hours of manual work per year. And we expect the time savings to increase as we continue to expand our use of DocShifter.
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently.
“The quality and reliability of DocShifter is very good. The integration with our submission management system makes it seamless to generate submission-ready PDFs, and the volume of PDF features eliminates most of our manual work.”
Jennie May – Director, Regulatory Operations
PharmaLex
5 minutes saved per document
PharmaLex saves 5 minutes per document, across thousands of documents they process every month.
With DocShifter, PharmaLex is able to publish eCTD leaflets a lot quicker, while maintaining essential quality and compliance.
Centralizing PDF conversion
PharmaLex was previously using licensed PDF plug-in tools to prepare content for inclusion in submissions. The process of converting the original source documents to fully compliant submission-ready documents was complex, manual and extremely time-consuming.
With DocShifter, PharmaLex is saving time and money while being able to automate most of the dull and repetitive tasks they used to have.
Accelerating submission publishing
Thanks to DocShifter’s wide range of PDF features, PharmaLex’s expert submission-publishing team is able to process more documents in a shorter amount of time.
PharmaLex is no longer manually editing PDFs for submission readiness. Hyperlinks, bookmarks, zoom levels, fonts, table of contents and many other compliance elements are handled automatically by DocShifter.
"They listen, and make it happen. Very quickly."
PharmaLex has had some specific requirements for creating submission-ready PDF renditions.
Due to the architecture, it is very easy to implement changes in DocShifter. We have listened to PharmaLex’s needs and suggestions, and have incorporated them in DocShifter in a short amount of time.
