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Following 12 months of significant international expansion, Phlexglobal, provider of its PhlexEview Trial Master File (eTMF) solution, , has announced its new corporate repositioning as ‘The TMF Experts©’, with a brand new image and website.
The repositioning is in response to the increasing global focus on Trial Master Files (TMFs) and international customer demand for both Phlexglobal’s eTMF solution and its paper and electronic TMF services. Phlexglobal’s ability to provide experienced resource at short notice to support preparation for Regulatory Inspections has also resulted in significant expansion of the UK office in Amersham, Buckinghamshire with a new site opening shortly, and a three-fold increase in headcount in the US office in Malvern, Pennsylvania.
Stella Donoghue, managing director of Phlexglobal, commented: “Our business has grown considerably in the past few years and that is largely due to the success of PhlexEview and our TMF quality services. We pride ourselves on our delivery of innovative, flexible and adaptable technology and resource solutions and it is these core values that have helped us grow and secure a market-leading position.”
Launched 12 months ago, the third generation PhlexEview solution is a customizable, 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. Incredibly simple and easy to use, PhlexEview meets the stated EMA requirements for usability, and has been presented as the primary TMF in Inspections. PhlexEview can be used as a Sponsor or CRO eTMF, or as an electronic Investigator Site File at Research Sites.
PhlexEview features the TMF Reference Model as its standard TMF structure. Global business development director at Phlexglobal and TMF Reference Model co-chair, Karen Redding, commented: “Utilizing the TMF Reference Model within PhlexEview provides a consistent standard structure across Sponsors and CROs alike. It provides a basis for re-mapping multiple disparate TMF structures, whether paper or electronic.”
Uniquely, Phlexglobal can also provide the processing capability and project management behind the eTMF, either PhlexEview or other systems, helping clients adhere to complex clinical trial compliance and regulatory requirements, controlled costs and increased productivity. Outsourcing complete TMF management in this way offers many advantages.
Karen added “Centralizing the TMF in this way provides a single access for both Sponsor and Inspector, facilitates centralized reporting and searching, provides the Sponsor with independent control over the TMF and simplifies the archiving process. A recent study TMF was closed six weeks early utilizing PhlexEview.”
PhlexEview can be used as an off-the-shelf package or can be highly customized, with or without the associated services offering complete adaptability and support.