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Recording Now Available: CTTI Releases New Resources for Adoption of a Quality by Design Approach

recording is now available of the public webinar held on Thurs., Nov. 12 to launch CTTI’s new resources for implementing a Quality by Design (QbD) approach to clinical trials. The webinar was led by Greg Pennock, EMD Serono; David Rodin, Amici Clinical Research; Karlin Schroeder, Parkinson’s Foundation; Ansalan Stewart, FDA; and Steve Young, CluePoints.

“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing , and thus demonstrating the value of Quality by Design,” said CTTI Executive Director Pamela Tenaerts, MD, MBA. “These new tools aim to help researchers implement QbD into their trial – an efficient approach that will help them focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.”


The specific resources that CTTI released include:


  • QbD Maturity Model: This self-assessment tool can be used by organizations to assess their current implementation of QbD, and to identify a desired future state.
  • Metrics Framework: This QbD Metrics Framework provides nine example metrics that can help key stakeholders in clinical research organizations to self-evaluate QbD implementation and guide continuous improvement efforts.
  • Implementation Guide: This resource helps study teams plan and evaluate their implementation of QbD for an individual clinical trial, and is intended to serve as a guide to key elements of QbD that will often be important to incorporate in trial planning and execution.
  • Documentation Tool: This tool helps study teams capture and communicate decisions about what is critical to quality and how the most important risks will be addressed.

CTTI’s QbD toolkit serves as a one-stop-shop for any individual or organization looking to implement QbD, and may help meet the anticipated new guideline for ICH E8(r1), which is expected to be finalized in 2021 and emphasizes a QbD approach to trial design.


Both the webinar and the new resources can be found on the CTTI website.