Phlexglobal has enhanced its electronic trial master file (TMF) 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, as constructed by more than 150 stakeholders from more than 100 companies across the pharmaceutical industry.
The combination of the TMF Reference Model's granularity for a TMF, including 222 different document types across 11 zones, together with Phlexeview's meta-driven search facility is said to enable easy location of documents within a TMF.
The page- and document turning process mimics the paper process while the metadata enables searching across centres, protocols or even compounds.
Phlexeview is a quality-controlled end-to-end process enabling the electronic searching and viewing of centralised TMF documentation from sponsors, subsidiaries, contract research organisations and field-based personnel from anywhere in the world at any time.
It will be further expanded later this year when version three is launched, which will feature 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 seamless interactions with systems such as Sharepoint and Documentum.
With more than 95 per cent of a TMF only ever being required for audit or inspection, this integration allows for centralised eTMFs without overloading any core document management systems.
