PhlexEview™ eTMF
Our extensive experience with trial master file (TMF) documentation and the industry requirements surrounding the storage and accessibility of the documents during and after a clinical trial has led us to believe that an electronic trial master file (eTMF) can greatly improve the quality and overview of a clinical trial. An electronic trial master file (eTMF) is a solution where appropriate documents are brought together in one secure 'virtual' location. These documents are scanned, indexed and backed up electronically, and are securely visible over the internet 24 hours a day.

PhlexEview™ is Phlexglobal's eTMF solution. It is a quality controlled end-to-end process which enables the electronic searching and viewing of TMF documentation. Paper and electronic documentation from sponsors, subsidiaries, CROs and field-based personnel is centralised from the start of a clinical trial and available for viewing securely over the internet - at any time of day from anywhere in the world. For end users, PhlexEview™ is simple and logical to navigate thereby reducing training requirements and costs.phlexeview

PhlexEview™ supports clinical trial management by removing the pain associated with the TMF and, by using the centralised yet visible documentation, creates a powerful and scalable management tool.

PhlexEview™ allows access over the internet at any time of day, from anywhere in the world. PhlexEview™ avoids the duplication and common end of study TMF reconciliation difficulties. PhlexEview™ also provides a complete electronic back-up of the documentation, working in accordance with the principles of relevant regulations such as 21 CFR part 11.

As an overview of the process each individual document is indexed according to the clients agreed TMF structure. The indexed documents are synchronised to a server located in a secure hosting environment and, through the PhlexEview™ search facility, documents are available for viewing and downloading over the internet. The paper TMF documentation can be filed securely in Phlexglobal's TMF rooms, which are fire and environmentally resistant. Phlexglobal can also perform quality control checks on the TMF documentation, prepare it for archive and provide a long-term archive service.

There is complete flexibility around the implementation of PhlexEview™ - specifically around the preparation, scanning and storage of the paper documentation. We work with clients to understand the requirements and then modify our solution to fit the client's needs. In other words, we can offer a totally bespoke solution that meets the business needs of each client.

Key features, benefits and resulting support of PhlexEview™:

Key Features Benefits Resulting Support
Centralised documentation Consistency
Security (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 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