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has announced the imminent launch of PhlexEview version 3, the third generation of its electronic Trial Master File (eTMF) solution.
PhlexEview 3 features an enhanced client-interface platform, system integration and the option of a “software as a service” model in response to Phlexglobal’s client requests and regulatory recommendations. It also features, as its standard TMF structure, the new DIA TMF Reference Model version 1.1, which was launched on February 9, 2011.
Phlexglobal’s eTMF solution, PhlexEview 3, is a quality-controlled, end-to-end process enabling electronic searching and viewing of centralized TMF documentation from sponsors, subsidiaries, CROs and field-based personnel from anywhere in the world at any time. Whether clients submit paper documents or upload electronic documents, use of PhlexEview 3 will ensure a regulatory compliant eTMF system can be presented to regulators and auditors.
Additions to PhlexEview 3 include new data import and export facilities, improved site architecture, and web services connectors to allow for seamless integration of defined documents with systems such as SharePoint and Documentum. This integration allows for centralized eTMFs without overloading enterprise-wide document management systems.
Other enhancements include features that support clinical trial management such as document comparison options and multiple quality control workflows. An expanded reporting module will be included for the first scheduled client implementations at the end of March 2011. These reports will allow for improved vendor and team oversight.