UK-based contract research organisation (CRO) Phlexglobal has signed a “landmark” contract with pharmaceutical company UCB to implement a complete trial master file (TMF) management solution.

The contract is worth £12 million over five years and will see Phlexglobal employ up to 30 new staff. It represents “a major achievement for Phlexglobal and will support our rapid expansion, both in the UK and US”, said Nicola Murgatroyd, founder and chief executive officer of the CRO, which specialises in clinical trial administration services such as document management and flexible staff resourcing.

Under the agreement, Phlexglobal will provide electronic and paper TMF management services for UCB global operations. This will include centralising UCB’s historical and ongoing global clinical trial files from Phase I through to Phase IV, using Phlexglobal’s PhlexEview ‘end-to-end’ TMF solution.

PhlexEview enables key users to have a complete overview of their study documents at any point in time, giving UCB critical business insights into the status and activity of all of its trial sites, Murgatroyd noted.

This facility that “would just not be possible when using paper TMFs and was one of the main influencers in UCB’s decision-making process”, she added.