Phlexglobal, the UK-based specialist support Contract Research Organisation (CRO), has signed a landmark contract with global biopharmaceutical company UCB to implement a complete trial master file management solution.

The new contract is worth £12 million, over the next five years, and will see Phlexglobal employ up to 30 new staff. Nicola Murgatroyd, Phlexglobal's founder and chief executive officer, commented: "The UCB contract win is a major achievement for Phlexglobal and will support our rapid expansion, both in the UK and US."

As part of the contract, Phlexglobal will provide electronic and paper trial master file (TMF) management services for UCB global operations. This will include centralising UCB's historical and ongoing global clinical study files from Phase I through to Phase IV using Phlexglobal's unique PhlexEview solution.

PhlexEview is an end-to-end TMF solution, which allows 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.   

"Perhaps the most interesting part of the solution is the management insight that will be provided to UCB. 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. This facility would just not be possible when using paper TMFs and was one of the main influencers in UCB's decision making process," continues Nicola.

Mark Hill, global head of global trial master file management for UCB added: "We are really excited about working with Phlexglobal and using its unique PhlexEview solution. 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."

Over the past few years Phlexglobal has increasingly seen significant interest in PhlexEview and its document management services illustrating the changes within the clinical research industry.

Nicola added: "With constant pressure to run clinical studies in the most efficient, reliable and cost effective manner, the industry must look for novel approaches to achieve this. UCB has approached this project with both innovation and receptiveness and has enabled the development of a strategic working partnership. This will assist them in responding to industry pressures whilst enhancing the quality and integrity of the TMF."

Based in Amersham, Buckinghamshire, Phlexglobal specialises in flexible staff resourcing, eTMFs, scanning, clinical trial management and support, archiving and training. With 17 of the top 20 global pharmaceutical companies as clients it is committed to achieving high levels of client satisfaction.