Despite progress toward paperless clinical trials, email and paper remain the dominant forms of exchanging trial documents with sponsors and CROs, according to a new survey from Veeva Systems.
The survey of 252 trial master file owners showed many electronic TMF users still rely on paper or simple electronic file systems—manual processes that significantly affect clinical trial operations.
Veeva, a cloud-based software developer, asked respondents to identify what is preventing their companies from going electronic, and whether the perceived barriers to going paperless were real, in “The Paperless TMF: An Industry Benchmark.”
The top barriers to going paperless were the cost of new eTMF technology, the implementation time and services costs and regulatory requirements, according to the survey.
“This research confirms not all eTMFs are created equal,” said Eldin Rammell, a clinical records management expert and managing director of Rammell Consulting. “Many eTMFs are simple file shares that perpetuate manual processes.”
However, some advanced users of eTMF realized costs savings and experienced major improvements with fewer misfiled documents. Nearly half (47%) of the respondents with an eTMF application gained greater visibility into trial performance metrics, versus 25% of cloud file system users. Those extensively leveraging metrics to improve the design or execution of trial processes are more than twice as likely to report business improvement from their eTMFs as those not using metrics, according to the survey. Advantages cited by respondents included better eTMF document quality, audit readiness and increased SOP compliance.
“Historically, the industry has focused on the rate of eTMF adoption in broad, general terms,” said Jennifer Goldsmith, vice president of Veeva Vault, the company’s regulated content management platform with applications for life science companies. “With this more in-depth look at which specific eTMF technologies, processes and metrics are used, we gain a comprehensive understanding of what is really driving improvements. Technology is a key aspect, but we now know the use of metrics to optimize trial operations is also having an impact.”
“There were also some misperceptions around the use of electronic and digital signatures in eTMF documents and the regulatory requirements around parts of the master file,” she said.
The lack of wider adoption of advanced eTMF usage is akin to Electronic Data Capture concerns more than a decade ago, said Goldsmith.
“We are seeing something very similar to what occurred 10 to 15 years ago with EDC,” she said. “Back then there was a transition from the paper case report forms to the electronic CRFs. The adoption curve was steep, until many saw the easier access, affordability and standardization—which is what’s needed with eTMF.”
