Introducing PhlexEview 4: the latest version of our marketing leading, best of breed eTMF management technology. Now with more capabilities than ever to optimize TMF management, PhlexEview 4 adds intelligent new ways of working; designed specifically to enhance the user experience, maximize efficiency, facilitate compliance, and improve oversight
2. Simplified Study Setup
• Easy study definition
• Easy to answer wizard-driven set
defines completeness requirements
automatically
• Study status can be defined
e.g. Locked status cannot submit or
change documents
• Simple to add countries and sites
• Simple to define milestones
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4. eTMF Event Management
• Pre-defined “Events” such as
Protocol Amendment available
• Automatically adds required
placeholders for each event
• User can manually change the
defaults or add other required
documents when entering an event
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6. Completeness
Dynamic completeness dashboard metrics
• Real-time oversight of eTMF
completeness
• View document pipeline status
• Drill into the data
• Fulfil placeholders on the same screen
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8. Intelligent Placeholders
• Placeholders generated dynamically
• Can be fulfilled by paper &
electronic documents
• Will automatically reconcile to
documents including bulk upload
• Can be “Excused” if no longer
required
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10. Quality Management
Definable Workflows
• Definable processing and QC steps
• Allocate steps to teams
• QC Sampling rates can be defined
• E.g. reduced percentage for
correspondence
• Priority artifacts can be defined up-
front and prioritized automatically
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11. Processing Management
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• Optimize your TMF process through defined processing and QC workflows
and work allocation features
• Define on a study-by-study basis which team will process the documents
(Internal or Phlexglobal)
Different studies within PhlexEview 4 can have different teams responsible for document processing
Scan/Upload
Index
QC
Study PXG-123
Processed by PXG
Scan/Upload
Index
QC
Study PXG-456
Processed by Sponsor
12. Oversight & Reporting
Dashboards
• Dynamic charts display specific
metrics
• Choose Dashboards appropriate to
your study role
• Save favourites for quick access
• Configure charts to display selected
metrics
• Save charts to PDF
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14. For a full system demonstration contact:
info@phlexglobal.com 4
Hinweis der Redaktion
Configuring a study to track expected documentation does not need to be a tedious or technical process. Simply answering pre-defined questions during study setup will give the system the information to accurately track completeness based on industry best practice or tailored to fit your company’s needs.
Expected Document List setup automatically after answering the Q&A
Instead of seeing the filing structure and having to answer how many docs expected at each node for each level (Trial / Country / Site) just answer a set of simple questions to get the same result
Study management after initial setup is just as easy, adding participating countries and sites will also automatically track completeness for those entities as well
Associate milestone targets for the study, countries, and sites to track timeliness metrics
There are often expected and unexpected events that occur during the trial.
PhlexEview provides a way to easily alert the eTMF of these events so completeness and placeholders can be updated quickly and easily in reaction to those events.
E.g. protocol Amendment – the event will automatically generate new place holders
Events can be raised at various levels such as Site or Protocol
Timely (Real Time) / relevant / Interactive
The intuitive reporting of the on-screen completeness enables you to quickly see and take action on relevant data as you navigate through the TMF
Directly from the document view screen, you are able to quickly and easily see the completeness for the area you have navigated to. For example, drilling down to a particular site in the document view will automatically calculate the completeness for that site.
Modify the report by grouping by metadata fields (e.g. Zone) to better fit your task
Placeholders provide a visual indicator of Expected Document List based on ANSWERS to QUESTIONS as well as an intuitive way to add documentation to the TMF.
TMF Health is now built into PhlexEview for real-time feedback
Placeholders generated dynamically
Based on answers to completeness questions
Answers may be changed during the study, triggering an adjustment in placeholders and completeness reports
Studies that start without placeholders can retro-actively add them if desired and PhlexEview will process the expected documents against what is already filed to take advantage of the benefits of placeholders without tedious mapping
A matching placeholder is not required to add a document to the eTMF
Easily define the “best practice” document process and override where necessary due to specific needs of your business, of the study, or even resource constraints.
QC Sampling allows for different levels of QC for different documemts
e.g. Correspondence could be a very low sample, but 1572’s may be 100% sampled
Priority documents will be presented for workflow steps first
Optimise use of your resources
Optimizing your TMF requires more than just technology, TMF expertise, good process management, and resources are key to an efficient and inspection ready TMF.
A streamlined document process can be difficult to achieve because often the process is different between studies and even within a study.
In PhlexEview, the technology allows for all of these components to work together in an effective way. With the document processing broken down into discrete steps, and allowing for intelligent assignment of tasks based on rules, teams can run with optimal efficiency with fewer errors and less re-work.
Seeing personalized reports that give you the information you are most interested in is the goal of the new Dashboards in PhlexEview.
The dashboard will be shown as you log in and is configurable to show the reports and data that you care about most.
