Phlexglobal, a UK-based specialist support contract research organisation (CRO), has signed a contract with biopharmaceutical company UCB to implement a trial master file (TMF) management solution.
The contract, worth GBP12m over the next five years, will see the company provide electronic and paper TMF management services for UCB's global operations.
This will include centralising UCB's historical and continuing global clinical study files from Phase I through to Phase IV using the Phlexeview solution.
Phlexeview is an end-to-end TMF solution that enables the logical electronic searching and viewing of TMF documentation once it has been prepared, scanned and indexed into the system.
Preparing for archive, TMF QC checking and archive storage completes the management cycle.
Nicola Murgatroyd, Phlexglobal's founder and chief executive officer, said: 'Phlexeview allows key users to gain a complete overview of their study documents at any one point in time.
'This, in turn, will provide UCB with business-critical information on the status and activity at all study sites,' she added.
Mark Hill, global head of TMF management for UCB, said: 'Online document viewing is a new concept for many of our staff but we believe it is going to make our processes so much quicker and smoother.
'The eight-week pilot programme we ran over the summer was a great success and I'm looking forward to building on these positive foundations,' he added.
Based in Amersham, Buckinghamshire, Phlexglobal specialises in flexible staff resourcing, eTMFs, scanning, clinical trial management and support, archiving and training.