• 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 » New Resources Help Trials Incorporate Quality by Design

New Resources Help Trials Incorporate Quality by Design

November 23, 2020

Four new tools from the Clinical Trials Transformation Initiative (CTTI) help sponsors and sites incorporate quality-by-design (QbD) principles in their trials.

The new tools include a metrics framework for measuring the effects of QbD, a maturity model to assess a site’s readiness to implement QbD and a guide to implementing QbD for individual trials. CTTI also has developed a set of spreadsheets that help plan and document QbD activities.

The new tools join CTTI’s QbD suite, which includes recommendations for monitoring quality assurance, recommendations for incorporating QbD principles, a guide to QbD principles, and a set of templates, guidelines and videos to help implement them.

Advancing QbD is one of five goals CTTI has set for improving clinical trials by 2030 (CenterWatch Weekly, Sept. 21). The other goals are increasing patient-centricity and accessibility, fully integrating clinical research with health processes, leveraging available data and focusing more on improving public health.

Other areas in which CTTI is developing resources include mobile clinical trials, master protocol studies and use of real-world data.

View CTTI’s QbD tools at https://bit.ly/36Xi2LE.

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