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New e-clinical master file solution launched

Phlexglobal, a UK-based specialist CRO for clinical trial administration and study support, launches an electronic Trial Master File solution

Phlexglobal, a UK-based specialist CRO for clinical trial administration and study support, has launched an electronic Trial Master File (TMF) solution called PhlexEview.

PhlexEview, which is an end-to-end TMF solution, allows logical electronic searching and viewing of TMF documentation from sponsors, subsidiaries, CROs and field-based personnel.

Documentation is centralised from the start of a clinical trial and available for viewing from anywhere at anytime, avoiding the common end of study TMF reconciliation difficulties. The system is simple and logical to navigate and requires minimal training, says the firm.

PhlexEview prepares each individual paper or electronic document, scanning the paper and indexing according to the agreed TMF structure. The indexed documents are then synchronised to a server located in a secure hosting environment and, through a search facility, documents are then available for secure 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, or can be returned to the user. The power of PhlexEview is in its flexible, free text search facility which makes it easy to locate any document or set of documents required. Searching can be done either within or across protocols, centres or sections, with the additional facility of advanced searches using free text, date of document and date of synchronisation.

The system delivers a powerful communication tool to the clinical trial management team, offering immediate access to documentation and bespoke management information. Quality is a key feature of the PhlexEview process; all tasks are undertaken by qualified personnel.

PhlexEview allows flexibility regarding company workflow processes, location, resource allocation and exporting of documents to other systems to assist eCTD preparation. The system can also perform quality control checks on the TMF documentation and prepare it for archive. The company will be promoting PhlexEview at the Partnerships in Clinical Trials conference in Amsterdam in November 2007.

Karen Roy, head of business development, said: "PhlexEview is going to promote resource efficiency, improve communication and provide a powerful management tool for the clinical team. No longer will you have to dedicate resource to end-of-study reconciliation. Reviewing TMFs can be done from any convenient internet connection. Line, project, departmental or even outsourcing managers can produce bespoke searches to give them detailed insight into the management of studies."

30th September 2008

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