There has been a significant increase in the number of CROs using electronic trial master file (eTMF) applications from just one year ago, according to a report from Veeva Systems, a San Francisco Bay Area-based provider of cloud-based software. The “Veeva 2015 Paperless TMF Survey: Annual CRO Report” was a global study of TMF owners that found 38% of CROs surveyed now use eTMF applications versus just 21% in 2014. A number of benefits are prompting CROs’ adoption of eTMF technology. More than half (58%) say faster study startup is a key driver, while 50% cite cost savings.
The industry-wide study also shows a notable shift away from paper and paper-based processes. CRO respondents are adopting electronic processes across content-intensive areas, including clinical operations, regulatory, drug safety and data management. The data management area saw the largest decrease in its use of paper, down from 27% in 2014 to 8% in 2015. Clinical operations, which manages the greatest number of TMF documents overall, also saw a sharp decline from 47% in 2014 to 34% in 2015.
CROs that have implemented an eTMF solution report a broad range of benefits impacting all aspects of the TMF. When it comes to inspection-readiness, particularly, most CROs see improvements in the number of missing documents (92%); misfiled documents (89%); duplicate documents (86%); incomplete documents and/or missing signatures (84%); and expired documents (81%). Additionally, Veeva found more than half (57%) report improved audit- and inspection-readiness as a result of eTMF adoption.
“Over the last two years, the industry has embraced eTMFs in unprecedented fashion. At Advanced Clinical, it is rare to receive requests for anything other than eTMF services because the benefits are so clear. Clients and CROs see results in real-time, with full visibility and added study controls, which enhance audit-readiness overall,” said Julie Ross, executive vice president of CRO operations at Advanced Clinical, a global supplier of drug development services.
When asked about the potential impact of using metrics to shorten clinical trial times, the majority of CROs say insights into processes associated with study startup would have the greatest benefit. More than two-thirds (70%) cite the importance of information about the time from site section to Institutional Review Board approval and time to collect essential site documents (68%).