Overview
Avoiding errors, collecting data that is fit-for-purpose, and reducing patient burden are just a few of the many benefits of applying Quality by Design (QbD)—an approach that focuses resources on the errors that matter to decision making during a trial.
CTTI has built a suite of resources—including recommendations for monitoring, recommendations for QbD, a principles document, and a QbD toolkit—that outlines how to apply QbD principles in clinical trials. More recently, we created additional resources—a metrics framework, maturity model, implementation guide, and documentation tool—to help organizations and individual trial teams effectively implement a QbD approach for their trials.
Learn how other organizations have used CTTI’s QbD recommendations to design and conduct better clinical trials.
Solutions
Search AllRecommendation Summary
Recommendations
- Recommendations for Quality by Design
- Recommendations for Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials
Resources
- Critical to Quality (CTQ) Factors Principles Document
- Quality by Design Maturity Model
- QbD Maturity Model Walkthrough and Scoring Examples
- Quality by Design Metrics Framework
- Quality by Design Documentation Tool
- Components of QbD Adoption
- Case Study: University of Oxford CTSU
- Case Study: DCRI Streamlines Protocol Using Quality by Design Thinking
- Case Study: Emphasis on Protocol Design Helps Alexion with Timeline Adherence
- Case Study: The Medicines Company Developed Nimble Protocols to Scale for Global Trials
- Measurement for Individual Study Teams: Leverage Plan–Do-Check-Act Approach
- Quality by Design Implementation Guide for Individual Clinical Trials
- Team Recognition and Ownership of the Process: Helpful Hints
- Setting Expectations
- Case Study: A Study to Evaluate the Efficacy and Safety of XXXX compared to YYYY in the Treatment of Patients with Acute Episode of Schizophrenia (Hospitalized)
- Case Study: Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer
- Case Study: A prospective, multicenter, single-arm, clinical cohort study
- Case Study: Renin Angiotensin System Combination Antagonists for Life (RASCAL)
- Quality by Design Workshop – Facilitator Role
- Perspectives for QbD Discussions and Potential Champions
Related Items
- Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials
- Designing High-Quality COVID-19 Treatment Trials
- Quality by Design – From Concept to Implementation and Beyond
- Enhancing clinical evidence by proactively building quality into clinical trials
- Quality by Design Project: Recommendations and Toolkit
- New Recommendations to Improve Quality in Clinical Trials
- Translating Quality by Design Principles into Practice, Part 3
- Translating Quality by Design Principles into Practice, Part 2
- Translating Quality by Design Principles into Practice, Part 1
- Workshop on Quality Risk Management: Understanding What Matters
- Workshop on Quality Risk Management: Understanding What Matters
- Clinical Trials: Rethinking How We Ensure Quality
- Workshop on Quality Risk Management: Understanding What Matters
- Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose
- Monitoring the Quality of Conduct of Clinical Trials: A Survey of Current Practices
- Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach
- A CTTI Survey of Current Monitoring Practices
- Quality Objectives of Monitoring
News
- New Case Studies Reveal Real-World Experience with Quality by Design (QbD)Organizations are gaining experience using CTTI’s Quality by Design (QbD) recommendations to design and conduct better clinical trials. CTTI today announced four new QbD case studies, adding to its robust QbD toolkit. Three ...
Case Study
- FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers
- Bristol Myers Squibb (BMS) Co-Hosts Quality by Design Workshop with CTTI to Achieve Quality Culture Aligned with ICH E8(R1)
- Rho Combines CTTI Resources to Operate with Optimal Efficiency and Data Quality
- University of California Irvine’s Multidisciplinary Trial Design Studios Yield Streamlined, Considered Protocols
- Quality by Design Helps EMD Serono Streamline its Protocol Through Inclusion of New Perspectives