What is PhlexEview?

PhlexEview is Phlexglobal’s electronic Trial Master File (eTMF) system and associated best practice processes which enable the production of a regulatory compliant eTMF in accordance with 21 CFR part 11.

PhlexEview is a hosted solution which enables the electronic searching and viewing of centralised TMF documentation.  As PhlexEview is a combination of system and services, there is complete flexibility as to the offering Phlexglobal can provide:

1. Functional service provision of trial master file management, including processing and quality control of all paper and electronic documents. Paper documents would be centralised in Phlexglobal’s UK or US offices and stored in controlled Records Centres. In this case, the PhlexEview eTMF system is provided at no cost, as a supporting tool for our service delivery
2. eTMF system provision for the management of electronic files, where Phlexglobal provides a quality control service on all files submitted. Phlexglobal maintains user management and study set-up and management. Again the eTMF system is part of our service delivery
3. Software as a Service (SaaS), where Clients utilise the software, and provide the majority of the processing and quality control themselves. Phlexglobal would provide guidance around processes to be followed
4. Quality control checking of the content of TMFs
5. Paper and electronic archiving

PhlexEview Functionality

Key Features and Benefits of PhlexEview

DIA TMF Reference Model in PhlexEview

PhlexEview has been enhanced with the integration of the DIA TMF Reference Model as the standard TMF structure for the system.

The TMF Reference Model is a single, unified interpretation of ICH-GCP and other regulations in the form of a list of TMF documents, as constructed by more than 150 stakeholders from over 100 companies across the pharmaceutical industry.

The combination of the TMF Reference Model’s significant granularity for a TMF, including 233 different document types across 11 zones, together with PhlexEview’s powerful metadata-driven search facility enables effortless location of documents within a TMF.

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