- CTTI Launches New Resources to Support Quality by Design in Clinical Trials October 28, 2026As part of its ongoing commitment to improving the quality and efficiency of clinical trials, the Clinical Trials Transformation Initiative (CTTI) has launched two new resources to help clinical research teams apply Quality by Design (QbD) principles throughout trial design and development.
Recent News Feed
- CTTI Launches Quality by Design Workshops for Study Teams September 14, 2026
- CTTI Releases Enabling Expedited Pathways Booklet to Explore Use of FDA Expedited Programs August 31, 2026
- CTTI Publication Provides Recommendations for Disease Progression Modeling in Medical Product Development August 6, 2026
CTTI News + Happenings
Ensuring Quality | Webinars
Advancing Quality by Design in Clinical Trials: Practical Tools for Better Trial Design
CTTI Project: Quality By Design, Collaborative Engagement in Clinical Trial Design SHARE TO: Webinar Objective On October 7, 2026 CTTI introduced two new resources to help clinical research teams...
Ensuring Quality | CTTI News
CTTI Launches New Resources to Support Quality by Design in Clinical Trials
As part of its ongoing commitment to improving the quality and efficiency of clinical trials, the Clinical Trials Transformation Initiative (CTTI) has launched two new resources to help clinical research...
CTTI News
CTTI Launches Quality by Design Workshops for Study Teams
CTTI now offers a facilitated Quality by Design (QbD) Workshop designed to help study teams identify critical-to-quality (CTQ) factors and proactively manage risk during trial design, before protocol lock.
CTTI News
CTTI Releases Enabling Expedited Pathways Booklet to Explore Use of FDA Expedited Programs
CTTI has released the Enabling Expedited Pathways booklet, the first deliverable from an ongoing project examining the use of U.S. Food and Drug Administration (FDA) and other international regulatory expedited...
Publications
CTTI Publication Provides Recommendations for Disease Progression Modeling in Medical Product Development
Disease progression modeling (DPM) has the potential to support greater efficiency and better decision-making in clinical development, yet it remains underutilized compared with more established model-informed drug development approaches.
Artificial Intelligence | CTTI News
New Resource Highlights Key Insights from the FDA/CTTI Workshop on Artificial Intelligence in Drug and Biological Product Development
A new summary captures key themes and insights from the FDA/CTTI Workshop on Artificial Intelligence in Drug and Biological Product Development, including current and emerging AI applications, implementation challenges, and...
Patient Engagement | CTTI News
CTTI Releases Executive Summary from Patient Summit
On April 28, 2026, patients, caregivers, and advocates gathered for the CTTI Patient Summit to discuss perspectives on the use of AI in clinical trials, the reuse of patient data,...
Patient Engagement | CTTI News
Designing Trials for the Data We’ll Need Next: Dana Lewis on Participant Burden, Researcher Burden, and Consent in the AI Era
In advance of CTTI’s Patient Summit, Dana Lewis spoke with Morgan Hanger about data capture, consent, researcher assumptions, and why many trials remain anchored in outdated models.
CTTI News
Holiday Greetings from CTTI: Bridging Vision and Impact in 2025
Highlighting a year of progress, partnership, and impact across the clinical trials ecosystem.
Artificial Intelligence | Webinars
Artificial Intelligence in Drug & Biological Product Development Hybrid Public Workshop 2025
Access the agenda, slides, and recording from the 2025 AI in Drug and Biological Product Development Hybrid Public Workshop.
Artificial Intelligence | CTTI News
FDA, CTTI Convening 2025 Hybrid Public Workshop on Artificial Intelligence in Drug & Biological Product Development
Registration is now open for the second Hybrid Public Workshop on Artificial Intelligence in Drug and Biological Product Development, hosted by the U.S. Food and Drug Administration in collaboration with...
Regulatory Submissions + Approvals | Webinars
CTTI’s Disease Progression Modeling Recommendations & Tool Launch
Webinar Launching Disease Progression Modeling Recommendations and Framework
Regulatory Submissions + Approvals | CTTI News
CTTI Releases New Recommendations to Guide Use of Disease Progression Modeling in Medical Product Development
CTTI today released new recommendations to support the effective use of disease progression modeling (DPM) in medical product development.
CTTI News
Optimizing Flexibility and Data Quality in Clinical Trials: Bringing Clarity to DIA Global 2025
At this year’s DIA Global Annual Meeting, Lindsay Kehoe, senior project manager at the Clinical Trials Transformation Initiative, chaired a panel under Track 8 – R&D Quality and Compliance –...
Clinical Trials Landscape | CTTI News
New CTTI Project Aims to Develop Framework for Assessing U.S. Clinical Trial Site Capacity and Readiness for Public Health Emergencies
In recent years, concerns have been raised about the limited real-time awareness of U.S. clinical trial sites’ capacity and capabilities, including their ability to support a coordinated and effective response...
Innovative Trials | CTTI News
CTTI to Launch New Recommendations on Disease Progression Modeling in Free Public Webinar
CTTI will host a free public webinar on Tuesday, July 8, to introduce new recommendations for using disease progression modeling (DPM) to improve medical product development.
CTTI News
Inside the State of Clinical Trials: Perspectives, Problems, and Pathways Forward
The Clinical Trials Transformation Initiative (CTTI) convened 150 clinical trials leaders, patients, policy influencers, and trialists in Washington, D.C., on May 22 for a dynamic meeting focused on the state...
Events
Bioethics International & EY 2025 Roundtable: Ethics, Trust + Patient Centricity in Pharma – Defining Metrics for Success
Establishing a Global Industry Reporting Standard for Clinical Research Data: Public health, ethics, and business considerations in response to Declaration of Helsinki
Media Coverage
From crisis to resilience: how clinical trials can absorb future trade shocks through AI and blockchain
Source: Health Tech World