• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » TMF survey: technology adoption lagging, many sticking to paper and email

TMF survey: technology adoption lagging, many sticking to paper and email

June 16, 2014
CenterWatch Staff

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.”

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • tablet

    Digital Intake Platforms Effective as Source of Trial Information, Survey Shows

  • Diversity-360x240.png

    Site Spotlight: EmVenio Research Takes to the Road to Promote Trial Diversity

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing