Slowly but surely... CROs gradually shifting to paperless trials, says Veeva

30-Aug-2015 - Last updated on 31-Aug-2015 at 14:47 GMT

CROs still slow to move to electronic or cloud-based TMF systems, says Veeva

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Clinical trial operators are slowly converting to electronic Trial Master Files (eTMFs) but almost a third still rely on paper to manage data, according to cloud-based software provider Veeva.

While Veeva Systems reported a 30% year-on-year increase in revenues to $98m (€87m) for its second quarter FY2016 last week, CEO Peter Gassner told investors there are ample opportunities to grow further in an industry which is still, in many aspects, managing data manually.

“The content management landscape in life sciences is predominantly one of legacy client server and homegrown systems as well as paper and manual processes,” he told investors in a conference call. “We are now moving this to the cloud with a set of integrated best-in-class solutions.”

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One solution Veeva offers is its cloud-based Vault eTMF system for managing clinical trial data. The product was launched in 2012 and is one of a number of eTMF software systems commercially available, but according to a company spokesperson, Veeva is seeing “a surprising number of life sciences companies, including CROs, that are still using paper and manual processes.”

However, “that is slowly beginning to change,” Outsourcing-Pharma.com was told. “A growing number of CROs are switching to electronic processes and systems [and today] four of the top eight global CROs leverage Veeva Vault eTMF to support sponsors.”

A 2015 study of Trial Master File (TMF) owners produced by the company found that 31% of respondents still managed ‘most or all’ TMF documents on paper, but this is down 12 percentage points from 43% last year, the firm added.

“In addition, one in four respondents now report using eTMF applications to exchange TMF documents between sponsors and CROs, up nine percentage points from 2014,” the spokesperson continued.

While the cloud-based software has been available for quite a long time, and has been picked up quickly by other industries, uptake by life sciences companies has been hindered by the need for “a highly tailored, industry specific solution,” rather than a generic cloud-based product, we were told.

“All signs point towards a gradual, but certain, transition to paperless trials…it’s just a matter of how long it may take.”