Under the £12m (€13.7m) contract, Phlexglobal will use its PhlexEview tech to build a central electronic record of UCB’s trial master files (TMF) for both ongoing and historical Phase I to IV trials.
The UK firm said that the project, which will be undertaken over the next five years, will create as many as 30 new jobs in functions ranging from document preparation to scanning and indexing.
While the work is primarily focused on helping UCB manage its various global trial programmes, the approach is likely to provide wider benefits according to Phlexglobal CEO Nicola Murgatroyd.
She told Outsourcing-pharma that UCB will benefit from “improved inspection readiness, global visibility of TMF documentation, improved vendor oversight, strengthened business continuity and increased efficiency through reduced costs.
“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.”
Murgatroyd added that such an overview “will provide UCB with business critical information on the status and activity of all study sites,” which, she suggested, is something that it just not possible with a paper TMF system.
TMF and e-TMF hot topics
Phlexglobal’s eTMF deal with UCB could be a sign of things to come according to Murgatryod, particularly as the management of trial documentation becomes increasingly complicated by the trend to conduct clinical research at multiple sites around the world.
She suggested that: “The increasing global spread of clinical trials has resulted in more disparate TMFs and reduced visibility, this is driving eTMFs forward as a solution to the problem.
“Phlexglobal is currently establishing a global presence to deal with client demand. There is a strong interest in PhlexEview from Japenese owned organisations. eTMF initiatives are generally being driven centrally rather than region specific.”
Murgatroyd went on to say that the need to improve efficiency and oversight were also driving demand for eTMF solutions, which she said are “fast becoming essential” for trial management.
She added that the pharma industry “The industry is clearly seeing the advantages of an electronic trial master file and the benefits of outsourcing this function.”
Further evidence of the growing importance of eTMF is provided by the UK Medicine and Healthcare products regulatory Agency’s (MHRA) decision to hold a symposium on the subject in December.