Phlexglobal, the UK-based specialist contract research organisation (CRO) that last year undertook a management buyout with private equity backing, has announced a corporate repositioning as ‘The TMF Experts’ in response to growing demand for its Trial Master File services.
The revised strategic emphasis, revealed ahead of the Drug Information Association Annual Meeting in Philadelphia, US and including a new image and website (www.phlexglobal.com), follows 12 months of significant international expansion at Phlexglobal, which pioneered the first commercial electronic Trial Master File (eTMF) solution, PhlexEview.
The repositioning reflects increasing global focus on Trial Master Files as well as international customer demand for both Phlexglobal’s eTMF solution and its paper and electronic TMF services, the company explained.
Phlexglobal’s ability to provide experienced resource at short notice to support preparations for regulatory inspections has also resulted in a marked expansion of the company’s UK office in Amersham, Buckinghamshire, where a new site will open shortly, and a three-fold increase in headcount at the US office in Malvern, Pennsylvania, it added.
“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,” commented Stella Donoghue, managing director of Phlexglobal.
Launched 12 months ago, the third generation PhlexEview solution is a customisable, end-to-end process that enables centralised TMF documentation from sponsors, subsidiaries, CROs and field-based personnel anywhere in the world to be searched and viewed electronically at any time.
Phlexglobal also offers the processing capability and project management behind an eTMF, using PhlexEview or other systems. This helps clients to meet complex compliance and regulatory requirements for clinical trials, control costs and boost productivity, the company points out.
“Centralising the TMF in this way provides a single access for both sponsor and inspector, facilitates centralised reporting and searching, provides the sponsor with independent control over the TMF and simplifies the archiving process,” noted Karen Redding, business development director at Phlexglobal.