A new electronic Trial Master File (TMF) solution that promises to “promote resource efficiency, improve communication and provide a powerful management tool for the clinical team” has been launched by UK-based contract research organisation (CRO) Phlexglobal.
The company, which specialises in clinical trial administration services such as document management and ethics committee submissions, describes PhlexEview as a “unique” end-to-end solution that requires minimal training and allows TMF documentation to be searched and viewed “from anywhere at anytime”. Documentation can be centralised from the start of trial and accessed by trial sponsors, subsidiaries, CROs or field-based personnel, avoiding “the common end-of-study TMF reconciliation difficulties”, Phlexglobal says.
Individual paper or electronic documents are scanned and indexed according to the agreed TMF structure. The indexed documents are then synchronised to a server located in a secure hosting environment and made available for secure viewing and downloading over the internet through the PhlexEview search facility.
“The power of PhlexEviewTM is in its flexible, free-text search facility, which makes it easy to locate any document or set of documents required,” Phlexglobal commented. “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.” As an additional service, the company can perform quality control checks on the TMF documentation and prepare it for archive.
“No longer will you have to dedicate resource to end-of-study reconciliation,” said Karen Roy, Phlexglobal’s head of business development. “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.”