JUN 20, 2014 12:00 AM PDT

Survey Shows That Lagging Technology Impacts Clinical Trial Operations

At the Drug Information Association's (DIA) 50th Annual Meeting, Veeva Systems released the results of the Veeva 2014 Paperless TMF Survey: An Industry Benchmark, the largest trial master file (TMF) survey to date. Veeva Systems Inc., which provides cloud-based software for the global life sciences industry, presented the findings on Tuesday, June 17.

The in-depth study of more than 250 TMF owners found that many (57 percent) still use paper or simple electronic file systems to manage their TMF. The data also show that those using advanced eTMF technologies experience greater inspection readiness, visibility, SOP compliance and cost savings from their eTMF than those using local or cloud file systems.

Respondents using more mature technologies, specifically process-driven eTMF applications and content management systems, derive greater benefit from their eTMF. For example, 47 percent of those with an eTMF application realize cost savings, as compared to only 29 percent of those using a local file system. TMF quality is also higher, as 81 percent of those with eTMF applications report good or major improvement in misfiled documents, compared to 62 percent of local file system users. Yet, today only about one in ten respondents (13 percent) use an eTMF application to manage their TMF.

The use of paper and electronic file systems to manage the TMF contributes to the industry's continued reliance on manual processes. The survey reveals that email (69 percent) and paper (57 percent) remain the predominant means of exchanging trial documents with sponsors/CROs.

"This research confirms not all eTMFs are created equal. Many eTMFs are simple file shares that perpetuate manual processes," said Eldin Rammell, a renowned clinical records management expert and managing director at Rammell Consulting. "In the face of MHRA's updated definition for critical findings, it is encouraging that organizations utilizing eTMF applications are experiencing significant benefits in inspection readiness and business efficiency gains."

Metrics usage is also connected to greater TMF quality and benefits. Nearly half (47 percent) of those with an eTMF application gain greater visibility into trial performance metrics, versus only a quarter (25 percent) of cloud file system users. Those extensively leveraging metrics to improve the execution and/or design of trial processes are more than twice as likely to report business improvements from their eTMF than those not using metrics. These advantages include better TMF document quality (63 percent and 29 percent respectively), audit readiness (56 percent and 25 percent respectively), and increased SOP compliance (49 percent and 16 percent respectively).

"Historically, the industry has focused on the rate of eTMF adoption in broad, general terms," said Jennifer Goldsmith, vice president of Veeva Vault. "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 are a number of drivers prompting the move to eTMFs; chief among them are cost savings (56 percent), faster study start-up (55 percent), improving remote and central monitoring (49 percent), and inspection readiness (45 percent). By contrast, respondents are far less likely to report barriers to going paperless. The most frequently cited barriers (major or insurmountable) are technology costs (38 percent), implementation costs (33 percent) and regulatory requirements (28 percent). While 38 percent of respondents see cost as a significant barrier to going paperless, an equal number (38 percent) report cost savings as a benefit of their eTMF.

The top capabilities required to go paperless are digital/e-signatures (66 percent), e-forms (65 percent) and secure access for external parties (62 percent). "It is interesting to note that most of the perceived barriers to eTMF adoption can be resolved using tested and proven technologies companies can implement in a very cost-effective manner," added Rammell.

The largest eTMF study to date, the survey examines the current state of eTMF adoption, as well as the benefits, drivers and barriers to implementing electronic processes. This research builds upon respected surveys conducted by the DIA TMF Reference Model group by providing additional insight into the remaining sources of paper and the types of eTMF utilized - with each question providing a different lens to understanding the industry's journey to a paperless TMF.
About the Author
  • Ilene Schneider is the owner of Schneider the Writer, a firm that provides communications for health care, high technology and service enterprises. Her specialties include public relations, media relations, advertising, journalistic writing, editing, grant writing and corporate creativity consulting services. Prior to starting her own business in 1985, Ilene was editor of the Cleveland edition of TV Guide, associate editor of School Product News (Penton Publishing) and senior public relations representative at Beckman Instruments, Inc. She was profiled in a book, How to Open and Operate a Home-Based Writing Business and listed in Who's Who of American Women, Who's Who in Advertising and Who's Who in Media and Communications. She was the recipient of the Women in Communications, Inc. Clarion Award in advertising. A graduate of the University of Pennsylvania, Ilene and her family have lived in Irvine, California, since 1978.
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