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PhlexEview™ eTMF

PhlexEview is Phlexglobal’s electronic Trial Master File (eTMF) solution, a quality controlled end-to-end process which enables the electronic searching and viewing of TMF documentation. All paper or electronic documentation from sponsors, subsidiaries, CROs and field-based personnel is prepared, scanned, indexed and centralised in PhlexEview where it is then available for viewing and tracking over the internet. PhlexEview is very simple and logical to navigate requiring minimal training.

Once indexed and stored in PhlexEview, the paper TMF documentation can be filed securely in Phlexglobal’s TMF rooms, which are fire and environmentally resistant, or can be returned to the client. 

The power of PhlexEview is in its flexible, free text search facility which makes it easy to locate any document or set of documents required. Searching can be done either within or across protocols, types of files (central study files or central investigator files), centres, sections, or sub-sections, with the additional facility of advanced searches using free text, date of document and date of submission. Additional search criteria can be added to create a bespoke eTMF interface if required.

There is complete flexibility around the implementation of PhlexEview in terms of the preparation, scanning and storage of the paper documentation. We work with clients to understand their requirements and then modify our solution to fit business needs.

With clinical studies being run in ever more disparate parts of the world, the challenges and risks associated with ensuring regulatory compliance and retaining document control (paper or electronic) increases. PhlexEview is a powerful and scalable document management solution and a study management tool delivering clients with centralised and accessible study documentation for CRAs, Study Managers and others to use in managing study activities, reviewing study progress, performing quality control checks and trend analysis.


Key features, benefits and resulting support of PhlexEview™:

Key Features Benefits Resulting Support
Centralised documentation Consistency
Security (restricted access)
Lack of duplication
No reconcilliation required
Less room for errors
Ease of finding documents
No risk of losing documents
Decreased workload (time efficiency)
Correct versions used
Secure electronic backup Supporting business continuity Unquatifiable cost to the business if TMF needs to be reconstructed
Visible 24/7 over the internet (thin client)

Oversight of staff and sub-contractors
Management information tool
Enhanced accessibility
Increased efficiency

Improved management of staff and sub-contractors
Improved understanding of trial progress
Ability to find documents easily
No travel to review. No copying required.
Open architecture Integration with systems Decreased time to CSR and eCTD production