Clinical trial operations could benefit from cloud-based master-file systems


Veeva survey finds wide disparities among trial operators and sites in managing clinical data

The 2014 Paperless TMF Survey: An Industry Benchmark is an effort by Veeva Systems (Pleasanton, CA) to measure both the extent and effect of managing data transfers for trial master files (TMFs), the foundational document for conducting a trial. Veeva, a developer of cloud-based systems for sales force automation, document storage and retrieval, and regulated communications (“approved email”) between manufacturers and healthcare providers, finds double-digit improvements with trial managers employing advanced eTMF systems in cost savings, audit readiness and SOP compliance, among other factors.

Jennifer Goldsmith, VP of Veeva Vault (the document-storage business of Veeva), characterizes today’s document-management processes in three categories: paper-based systems (with documents being digitized somewhere along the way); basic eTMF systems that depend on email communications (whether cloud-based or not); and advanced eTMF systems. Surprisingly, the survey found that the majority of trial managers surveyed still depend on paper (57%) and email (68%) are the predominant methods of exchanging documents today. Only 13% of respondents employ an advanced eTMF system today.

For those that do so, however, responses indicate that there are significant improvements in operational effectiveness, audit readiness and a basis for performing metrics as a trial proceeds. Goldsmith presented these results at the DIA annual meeting (San Diego; June 15-19), and the survey report is available here. The company has been marketing its Vault eTMF offering since 2012.

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