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International Clinical Trials

Built with Purpose

Innovation has long been the trademark of CROs and a key driver in the rapid growth and consistently strong financial performance of the sector, so it comes as no surprise that they are leading the switch from paper-driven processes to more efficient electronic trial master file applications (eTMFs) (1). The results of a new survey, however, seem to show that CROs are not only setting the pace for going paperless, but also driving the migration from passive to active trial master file (TMF) management – and reaping the rewards.

The ‘Veeva 2016 paperless TMF survey: CRO report’ is now in its third year, collating feedback from 217 TMF managers worldwide (2). This year’s results reveal a seismic shift throughout the industry toward eTMFs, with less than a quarter of CROs (22%) still using paper-based methods in clinical operations. More than half now archive documents electronically, and 46% collaborate in the same way. Furthermore, 31% use eTMF applications to share documents with sponsors – up from 24% in 2014.

But the move towards active eTMFs is the strongest indicator that something more significant than paperless documentation is occurring. Nearly one third of CROs now use purpose-built eTMF applications that enable active TMF management – an increase from 21% in 2014. The use of passive eTMFs has lessened significantly, with cloud file shares down by 12% and local file systems decreased by 10%. So what is an active eTMF, and why is it such a compelling proposition for CROs?

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Rik van Mol is Vice President of R&D Strategy at Veeva Systems and responsible for the Vault R&D suite of applications in Europe. He has been involved in business/IT consulting and regulated content management in the life sciences sector for nearly 20 years. Rik’s experience has been built on assisting clients through complex transformational programmes across the life sciences value chain, including clinical, regulatory, manufacturing and supply chain areas for some of the world’s largest companies.
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