Welcome!

News Feed Item

Largest-Ever TMF Survey Reveals Lagging Technology Adoption and Manual Processes Significantly Impacting Clinical Trial Operations

Today, 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 TMF survey to date. This in-depth study of more than 250 trial master file (TMF) owners found that many (57%) 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 utilizing more mature technologies, specifically process-driven eTMF applications and content management systems, derive greater benefit from their eTMF. For example, 47% of those with an eTMF application realize cost savings, as compared to only 29% of those using a local file system. TMF quality is also higher, as 81% of those with eTMF applications report good or major improvement in misfiled documents, compared to 62% of local file system users. Yet, today only about one in ten respondents (13%) 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%) and paper (57%) 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%) of those with an eTMF application gain greater visibility into trial performance metrics, versus only a quarter (25%) 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% and 29% respectively), audit readiness (56% and 25% respectively), and increased SOP compliance (49% and 16% 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%), faster study start-up (55%), improving remote and central monitoring (49%), and inspection readiness (45%). 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%), implementation costs (33%), and regulatory requirements (28%). While 38% of respondents see cost as a significant barrier to going paperless, an equal number (38%) report cost savings as a benefit of their eTMF.

The top capabilities required to go paperless are digital/e-signatures (66%), e-forms (65%), and secure access for external parties (62%). “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 Veeva 2014 Paperless TMF Survey: An Industry Benchmark, 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.

The findings from the Veeva 2014 Paperless TMF Survey will be presented at the DIA 50th Annual Meeting on Tuesday, June 17 during the 12:45 p.m. PT Innovation Theater session and the "Transforming Culture and Mindsets to Deliver a Higher Quality eTMF" session at 3:30 p.m. PT. Attendees of DIA Annual 2014 can visit Veeva’s booth #2240 for a copy of the executive summary. An online edition of the executive summary is available at veeva.com/tmf-survey-2014.

To learn more about the Veeva Vault eTMF application or the Veeva Vault family of content management applications, visit veeva.com/vault.

About Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 200 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit www.veeva.com.

Veeva 2014 Paperless TMF Survey Highlights

The Veeva 2014 Paperless TMF Survey explores the life sciences industry’s progress toward paperless clinical trials by gathering the experiences and opinions of 252 Trial Master File (TMF) owners. The goal of the research is to understand the impact of growing eTMF adoption as well as the drivers, benefits, and barriers to going paperless. The survey examines the success factors for fully electronic trials and gives an industry-wide view of where organizations fall on the spectrum of paper-based to paperless TMFs. Highlights from the survey include:

Usage of Paper and Types of Electronic Trial Master Files (eTMFs)

  • A majority of TMF owners rely on manual processes—paper (57%) or email (69%)—to exchange TMF documents between sponsors and CROs
  • Many (57%) use paper or simple file shares to manage their TMF
    • 13% paper
    • 18% cloud file share
    • 26% local file share
  • eTMF applications are used by 13% of respondents

Benefits Attributed to eTMF Solutions

  • Those using an eTMF application or a content management system achieved a significantly greater number of benefits than those using a local or cloud file system, including:
    • Improved audit and inspection readiness (51% vs. 28%)
    • Cost savings (45% vs. 31%)
    • Better visibility into key trial performance metrics (44% vs. 28%)
    • SOP compliance (40% vs. 21%)

Top Drivers and Barriers to Going Paperless

  • Top drivers motivating eTMF owners to go paperless are:
    • 56% cost savings
    • 55% speed study start-up
    • 49% remote and central monitoring
    • 45% audit and inspection readiness
  • Few see impediments to going paperless with roughly a third or fewer citing major barriers or barriers that can’t be overcome. These included:
    • 38% cost of new technology, yet an equal number (38%) report cost savings as a benefit of their eTMF
    • 33% implementation time and services cost
    • 28% regulatory requirements

Use of Metrics

  • Those using metrics extensively to improve trial execution and/or design realize greater benefits from their eTMF than those that do not collect data or utilize metrics, including:
    • Improved document quality/reduced QC findings (63% vs. 29%)
    • Improved audit and inspection readiness (56% vs. 25%)
    • Easier collaboration with sites (54% vs. 32%)
    • Increased TMF SOP compliance (49% vs. 16%)
  • Nearly half (47%) of those with an eTMF application gain greater visibility into trial performance metrics compared to a quarter (25%) of those with a cloud file system

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership abi...
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to transi...
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service.
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you ...
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
China Unicom exhibit at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE FDD, TD-LTE), fixed-line broadband, ICT, data communica...
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, will discuss some of the security challenges of the IoT infrastructure and relate how these aspects impact Smart Living. The material will be delivered i...
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...