Phlexglobal

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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Simplified Study Setup

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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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eTMF Event Management

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CompletenessDynamic 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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Completeness

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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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Intelligent Placeholders

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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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Processing Management • 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-123Processed by PXG

Scan/Upload

Index

QC

Study PXG-456Processed by Sponsor

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Oversight & ReportingDashboards• 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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Oversight & Reporting

For a full system demonstration contact: info@phlexglobal.com 4