8:30 to 9:00 am - Registration and Continental Breakfast
9:00 to 10:15 am - Keynote: What Enforcement Cases Teach Us About Quality Management (1.25 CE)
Sarah Moeller, MS
President and CEO, The Greenlight Group, LLC
Craig Garmendia, Ph.D.
Associate Director for Clinical Quality Systems, AstraZeneca
This keynote, jointly led by a former FDA Foreign Expert and a noncompliance expert, will share real-world insights from Quality Systems inspections resulting in major findings and enforcement actions. Attendees will examine common pitfalls and inadequate CAPA responses, gaining strategies to build stronger, more effective corrective actions. The session will provide practical tools to fortify Quality Systems and prepare teams for successful regulatory inspections.
10:15 to 10:30 am - Break
10:30 to 11:00 am - Revised (R3) Good Clinical Practice Guideline: Looking to the Future (.5 CE)
Abby Statler, Ph.D., MPH, MA, CCRP
Senior Director, AVEO Pharmaceuticals, Inc.
This session will provide an overview of the new features introduced with GCP (R3) and focus on how the newly designed principles emphasize the importance of quality.
11:00-11:45 am - Quality Management Systems: Design and Application (.75 CE)
Abby Statler, Ph.D., MPH, MA, CCRP
Senior Director, AVEO Pharmaceuticals, Inc.
This session will outline strategies for designing and implementing Quality Management Systems. Perspectives from the site and sponsor will be offered and examples of application will be presented.
11:45 to 1:00 - Lunch
1:00-2:00 Training and Tools Used to Assess and Control Risk within Clinical Trial Project Management (1.00 CE)
Janelle Allen, MS, CCRP
Professional Consultant & Corporate Trainer, Faculty, Miami University
This session will detail best practices in assessing and mitigating risk in clinical trial project management. Review of professional tools and training pathways will be investigated to optimally equip teams.
2:00-2:30 pm - Break
2:30-3:45 pm - Self-Monitoring Implementation and Tracking within a Comprehensive Cancer Center (1.25 CE)
Katrina Croghan
Director, Applied Clinical Research Program, St. Cloud State University
Effective self-monitoring of clinical trials is essential, not only for responding to trial needs in real time, but also for identifying opportunities in education, process improvement, and operational efficiency. This presentation highlights the self-monitoring strategy implemented by a Comprehensive Cancer Center, focusing on the use of both first- and third-party participant accrual data across individual trials. Mrs. Croghan will guide attendees through a center’s reporting framework, which tracks accrual metrics and facilitates communication between study teams and the enterprise Compliance and Quality Unit (CQU). The session will demonstrate how this approach supports timely reviews, enhances transparency, and strengthens trial oversight.
3:45 to 4:45 pm - Breakout: Case-Based Risk Assessment Discussions (1.00 CE)
Attendees will break out into smaller groups to participate in exercises discussing risk assessments.
4:45 to 5:00 pm - Day 1 Wrap Up / Q+A (0.25 CE)
Abby Statler, Ph.D., MPH, MA, CCRP
Senior Director, AVEO Pharmaceuticals, Inc.
8:30 to 9:00 am - Continental Breakfast
9:00 to 10:15 am - Understanding Systemic Non-Compliance (1.25 CE)
Nancy Wintering, MSW, LCSW, CCRP
Assistant Director of Research, Thomas Jefferson University
This session will provide an introduction to fraud and misconduct in clinical research. Noncompliance can occur on an individual or systemic basis. Ms. Wintering will provide an overview of definitions and ethical frameworks, and the cost and consequence of research misconduct. Discussion of scenarios will assist attendees in recognizing misconduct and identifying the underlying factors and risks that contribute to fraud and misconduct in research.
10:15 to 10:30 am - Break
10:30 to 12:00 pm - Audit and Inspection Readiness Part 1: From Notification to Close-Out (1.50 CE)
Alyssa Gateman, MPH, CCRP
Executive Director, Clinical Trials Office Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP
Director of Quality and Education, Clinical Trials Office, Yale Cancer Center
This session will cover the essentials of audit/inspection readiness, from pre-notification through close-out, including best practices for prospectively maintaining essential documents necessary for a successful audit/inspection. This session will also discuss audit/inspection conduct and offer tips and tools for successfully navigating audits/inspections.
12:00 to 1:00 pm - Lunch
1:00 to 2:00 pm - Audit and Inspection Readiness Part 2: From Exit Meeting to Response and Beyond (1.00 CE)
Alyssa Gateman, MPH, CCRP
Executive Director, Clinical Trials Office Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP
Director of Quality and Education, Clinical Trials Office, Yale Cancer Center
This session will build on the previous session, providing an in-depth discussion on conducting root cause analysis and developing corrective and preventative actions to address audit/inspection observations.
2:00 to 2:15 pm - Break
2:15 to 3:00 pm - Can we Really Conduct this Study? (.75 CE)
Tammy Neseth, MA, CCRP
Senior Manager Site Services, Quantum Leap Healthcare Collaborative
This session will provide attendees with strategies that will enable them to recognize when stress may be impacting themselves, their teams, and those they support in achieving quality outcomes. Techniques that could be utilized to reduce stress through both sustained or “in the moment” practices will be described.
3:00 to 3:45 pm - Leveraging QA and QC Trends for Targeted Training (.75 CE)
Janelle Allen, MS, CCRP
Professional Consultant & Corporate Trainer, Faculty at Miami University
This session will outline top QA and QC trends to elucidate ideal training and educational needs. It will help teams hone in on focus areas of interest to create efficiency and optimal performance.
3:45 to 4:45 pm - Interactive Hot Topics Panel: AI, DCTs, and More! (1.00 CE)
Abby Statler, Ph.D., MPH, MA, CCRP
Senior Director, AVEO Pharmaceuticals, Inc.
Alyssa Gateman, MPH, CCRP
Executive Director, Clinical Trials Office Yale Cancer Center
Janelle Allen, MS, CCRP
Professional Consultant & Corporate Trainer, Faculty at Miami University
Jessica Rowe, MA, MS, CCRP, CIP
Director of Quality and Education, Clinical Trials Office, Yale Cancer Center
Nancy Wintering, MSW, LCSW, CCRP
Assistant Director of Research, Thomas Jefferson University
Sarah Moeller, MS
President and CEO, The Greenlight Group, LLC
Executive Director, Clinical Trials Office Yale Cancer Center
The conference faculty will engage in an interactive discussion with the attendees, focused on key topics in clinical research: Artificial Intelligence, Decentralized Clinical Trials, and other topics brought forth by the attendees.
4:45 to 5:00 pm - Conference Wrap Up / Q+A (0.25 CE)
Abby Statler, Ph.D., MPH, MA, CCRP
Senior Director, AVEO Pharmaceuticals, Inc.