Webinars

Advancing Quality by Design in Clinical Trials: Practical Tools for Better Trial Design

Webinars | October 28, 2026

Topics Included: Ensuring Quality

CTTI Project: Quality By Design, Collaborative Engagement in Clinical Trial Design

Webinar Objective

On October 7, 2026 CTTI introduced two new resources to help clinical research teams apply Quality by Design (QbD) principles throughout trial design and development during a public webinar.

The Collaborative Engagement in Clinical Trial Design Roadmap provides stage-specific guidance for engaging essential contributors throughout protocol development, while the Introduction to Quality by Design Training Module offers foundational knowledge to support consistent application of QbD principles across clinical development teams.

Together, these resources are designed to help research teams identify risks early, incorporate diverse perspectives, and develop clinical trials that prioritize participant safety, data integrity, operational feasibility, and meaningful outcomes.

Webinar Presenters

  • Denise Snyder (Duke Office of Clinical Research)
  • Theresa Strong (Foundation for Prader-Willi Research)
  • Rebecca Kottschade (Mayo Clinic)
  • Ugur Sener (Mayo Clinic)

Webinar Resources

Collaborative Engagement in Clinical Trial Design Roadmap


*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Recent Webinars

Artificial Intelligence in Drug & Biological Product Development Hybrid Public Workshop 2025

Posted on by Hannah Faulkner

Webinars | November 4, 2025

Topics Included: Artificial Intelligence

Hybrid Public Workshop Resources:

Meeting Webpage

Full agenda

Download the full PowerPoint slide set

Meeting Recordings:

Welcome & Session 1: Where Are We Now?

Session 2: Data Quality, Reliability, Representativeness, and Access in AI-Driven Drug Development

Session 3: Model Performance, Explainability, Transparency, and Interpretability in AI-Driven Drug Development

Session 4: Navigating the Future of AI in Drug Development

Discussion & Concluding Remarks

Share Your Feedback

We welcome your questions and feedback about this workshop. If you have follow-up thoughts or comments on the topics discussed, please share them using the brief form linked below. Your input will help inform future discussions and events.

Submit Your Feedback

Recent News Feed

CTTI’s Disease Progression Modeling Recommendations & Tool Launch

Webinars | July 8, 2025

Topics Included: Innovative Trials, Regulatory Submissions + Approvals

CTTI Project: Using Disease Progression Modeling to Advance Trial Design and Decision Making

Webinar Presenters

  • Sara Calvert, Clinical Trials Transformation Initiative (CTTI)
  • Lindsay Kehoe, Clinical Trials Transformation Initiative (CTTI)
  • Efthymios Manolis, European Medicines Agency (EMA)
  • CJ Musante, Pfizer
  • Karthik Venkatakrishnan, EMD Serono
  • Tiffany Westrich-Robertson, AiArthritis
  • Theo Zanos, Northwell Health

Webinar Resources

DPM Recommendations

DPM Considerations Framework

Download full slide presentation

 

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Recent Webinars

Translating Quality by Design Principles into Practice, Part 1

Webinars | October 10, 2024

Topics Included: Ensuring Quality

CTTI Project: Quality by Design

Webinar Objective

This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about CTTI's QbD Project.

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

  • CTTI Quality by Design Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
  • Pfizer Experience by Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
  • Seattle Genetics Experience by Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
  • Q&A

Watch Translating Quality by Design Principles into Practice, Part 2

Recent Webinars

TransCelerate BioPharma Presents Risk Based Monitoring Initiative to CTTI Members


Webinar Presenters:

  • Craig Wozniak

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Agenda

CTTI and TransCelerate have been in an ongoing dialogue about their respective efforts, including, for example, how work related to risk based monitoring (RBM) may be integrated. This webinar features a presentation by TransCelerate highlighting their RBM initiative.

Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

CTTI Project: Single IRB

Download Slides

Webinar Presenters

  • Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

To share experiences from two research institutions about implementation of a central IRB model for multi-center clinical trials

Webinar Agenda

  1. Results from a randomized, controlled trial of central versus local IRB review
  2. The institutional policy resulting from study results and a summary of conclusions that can be applied more broadly
  3. The continuing role of the institution in research compliance
  4. Examples from a research institution that serves as a central IRB and relies on commercial, academic, and federal external IRBs for multi-center clinical trials
  5. Questions and Discussion

Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database

CTTI Project: Electronic Healthcare Data

PDF icon Download Slides

Webinar Presenters:

  • Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
  • Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University

Webinar Objective:

This webinar provides an update on the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.

Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This webinar discusses the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.

IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.

Patient Advocacy/Industry Partnerships to Accelerate Therapy Development

CTTI Project: Patient Group Engagement

Webinar Presenters:

  • Sharon Hesterlee, Ph.D., Vice President Research, Parent Project Muscular Dystrophy
  • Holly Peay, MS CGC, Vice President, Education and Outreach, Parent Project Muscular Dystrophy, and Director, DuchenneConnect Registry

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

Sharon Hesterlee and Holly Peay discuss the ways in which Parent Project Muscular Dystrophy (PPMD) has partnered with industry to accelerate therapy development for Duchenne Muscular Dystrophy.

Webinar Resources:

Preliminary Evidence from Sponsors & Investigators Using Mobile Devices

CTTI Project: Digital Health Trials

Webinar Presenters:

Project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips)

Webinar Objective:

In this webinar, project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips) provide an update on CTTI’s Mobile Devices Project, which focuses on scientific and technological challenges affecting the selection and use of mobile technologies in clinical research. The presenters share preliminary evidence gathered from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. Issues addressed in the webinar include:

  • Challenges affecting data management, validation, analysis, and security in mobile technologies;
  • Scientific and technical considerations in mobile device selection; and
  • Approaches to managing and reporting safety signals and adverse events.