• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » CROs Moving to Electronics, But Paper Still Prevalent, Survey Shows

CROs Moving to Electronics, But Paper Still Prevalent, Survey Shows

Computervs printed files
November 8, 2019
Colin Stoecker

While CROs are gung-ho on some new technologies to manage trials, they still rely heavily on paper-based systems, a new survey shows.

Electronic data capture (EDC), electronic trial master files (eTMF) and clinical trial management systems (CTMS) are increasingly in use, but half of CROs responding to the survey said they still use paper to manage information exchange with sites.

Because most sites still store their trial data in regulatory binders rather than electronic systems, CROs’ ability to share information with their sites electronically is limited, the survey says. Most respondents, 96 percent, said they experience significant challenges with exchanging information with sites, according to Veeva’s 2019 Unified Clinical Operations Survey Report.

Seventy-one percent of respondents had issues with tracking and reporting paper documents, 59 percent with misfiled or missing documents and 48 percent with manual document exchange.

Attempting to overcome these hurdles, 93 percent of respondents said they use a standalone EDC system, 77 percent use an eTMF system, 71 percent a randomization and trial supply management (RTSM) system, and 70 percent a clinical trial management system (CTMS).

The number of CRO respondents using an eTMF has tripled since 2014, with 60 percent of CROs now using a purpose-built eTMF application. Over the past five years, eTMF has steadily replaced CTMS, according to the survey.

EDC, RTSM, and CTMS systems in use by CROs are all up from 2017, with EDC, which is the most heavily used, showing a 7 percentage point increase.

Since 2017, RTSM saw a 19 percentage point increase due to the complexity of protocol design, according to the survey, and CTMS use increased 12 percentage points as CROs aimed to reduce costs and improve study quality, the survey said.

Although new types of software can be used for many different parts of trials, they are particularly effective in study startup.

Study startup is actually slower today than it was a decade ago, and CROs are working hard to develop apps and purpose-built software to expedite the time that it takes to bring a drug to market. According to the survey, 86 percent of trials experience a study startup delay.

Only about half of CROs surveyed use CTMS, eTMF, or internally developed applications for study startup. For example, 28 percent of CROs use custom study startup applications, more than twice as many as sponsors.

Tools used to manage study startup processes are still dominated by Excel, at 78 percent. A close second to manage study startup was CTMS at 51 percent, followed by using eTMF applications at 44 percent.

To improve study startup, 60 percent of CROs say it would be best to reduce the use of spreadsheets and manual processes.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 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

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

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