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has enhanced its electronic Trial Master File solution–PhlexEview–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..
The combination of the TMF Reference Model’s significant granularity for a TMF, including 222 different document types across 11 zones, together with PhlexEview’s metadata-driven search facility will enable location of documents within a TMF. The page and document turning process mimics the paper process whilst the metadata enables searching across centers, protocols, or compounds.
PhlexEview is a quality-controlled end-to-end process enabling the electronic searching and viewing of centralized TMF documentation from sponsors, subsidiaries, CROs, and field-based personnel from anywhere in the world at any time. It is one of the few eTMF solutions fully adopting the DIA TMF Reference Model.
The PhlexEview solution will be further expanded later this year when version 3 is launched, featuring an enhanced client-interface platform to bring it in line with Phlexglobal’s eTMF vision and client and regulatory requirements. System integration, both import and export, and web services connectors are key features of the enhancements, to allow for interactions with systems such as Sharepoint and Documentum. With over 95 per cent of a TMF only ever being required for audit or inspection, this integration allows for centralized eTMFs without overloading any core document management systems.