What do automotive assembly lines and modern clinical trials have in common? More than many people realize. As the clinical research enterprise implements the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice, clinical research teams are increasingly expected to apply concepts such as Quality by Design, Risk-Based Quality Management, Root Cause Analysis, and proactive risk mitigation, many of which originated from manufacturing quality systems.

This session will translate these concepts into practical applications for clinical research professionals by exploring how “factory tools” like the 5 Whys and Fishbone (Ishikawa) diagrams can strengthen Corrective and Preventive Action plan development, improve operational workflows, and support inspection readiness. Through real-world examples, attendees will learn how to move beyond superficial findings such as “human error” to identify true systemic contributors to noncompliance and quality issues while preserving the human-centered nature of clinical trials and participant safety oversight.

CEU: 1.0 ACRP

Speaker:

• Asma Khan, MS, MBBS, CCRC, CCRP, Associate Director, PRMS & Quality, Stanford Cancer Institute

While competency-based frameworks for clinical research coordinator (CRC) development are widely discussed, many organizations struggle to operationalize them in a way that is both scalable and adaptable to their unique workflows.

This session focuses on translating such frameworks into practice through a structured, “plug-and-play” approach. Attendees will be guided through a step-by-step method for implementation within their own organizations, regardless of size or structure, with attention paid to defining role-specific expectations, mapping CRC competencies to daily responsibilities, and establishing clear, measurable demonstration criteria. The session will also present adaptable templates, real-world examples, and lessons learned from implementation across varying levels of coordinator experience.

Attendees will leave with practical tools and a customizable model that can be immediately applied to improve onboarding, standardize competency evaluation, and support long-term workforce development.

CEU: 1.0 ACRP

Speakers:

• Jesse Fuhriman, Certified Clinical Research Coordinator, Rocky Mountain Clinical Research

• Kelsie Wetzel, Supervising Senior Certified Clinical Research Coordinator, Rocky Mountain Clinical Research

Independent research sites are navigating an increasingly complex environment shaped by consolidation, workforce challenges, evolving sponsor expectations, emerging technologies, and growing operational demands. While these changes create uncertainty, they also present opportunities for organizations whose staff and leaders are willing to adapt and evolve.

This session explores practical strategies research site professionals can use to strengthen resilience, improve operational performance, and position themselves for long-term success. Attendees will examine industry trends, assess organizational risks and opportunities, and evaluate approaches for workforce development, patient engagement, operational efficiency, strategic partnerships, and sustainable growth.

Using real-world examples and interactive discussion, attendees will leave with practical tools to assess organizational readiness and develop actionable plans to remain competitive, adaptable, and patient-focused in an evolving clinical research landscape.

CEU: 1.0 ACRP

Speakers:

• Gary Fiocco, CEO, PCRS Network, LLC

• Kalli Kniss, President/COO, PCRS Network, LLC

• John Neal, Founder & Chairman of the Board, PCRS Network, LLC

Strategic use of a clinical trial management system (CTMS) and integrated reporting tools is essential to operating high-performing clinical research sites. In this session, leaders from a national site network and a large academic medical center will share how robust reporting strategies and data governance standards drive operational efficiency, strengthen compliance oversight, and enhance financial transparency. The discussion will highlight how advanced analytics, forecasting capabilities, milestone tracking, and revenue dashboards support proactive risk management and improve sponsor performance. Attendees will gain a practical framework for transforming site-level data into enterprise-wide insights that enable financially sustainable growth.

CEU: 1.0 ACRP

Speakers:

• Angela Campbell, Senior Director, Clinical Trials Office, OSU Comprehensive Cancer Center

• Ginger Switzer, SVP Clinical Operations, Alliance for Multi-Specialty Research, LLC

Repeat audit and inspection findings often persist because Corrective and Preventive Action (CAPA) plans are written to close findings and not to solve the underlying process failures. This session will provide a practical framework for strengthening CAPA in clinical research using real-world case studies, root cause analysis methods, and effectiveness check strategies aligned to current regulatory expectations.

Attendees will examine common CAPA breakdowns, distinguish corrective from preventive actions, and learn how to build action plans that are specific, measurable, sustainable, and more likely to prevent recurrence. Through interactive discussion and applied examples, attendees will leave with practical approaches they can use to improve inspection readiness, strengthen quality systems, and reduce repeat findings across site and study operations.

CEU: 1.0 ACRP

Speaker:

• Pamela Gonzalez, Education & Research Director, Huron

Despite a growing emphasis on participant-centered clinical research, many informed consent forms, recruitment materials, and participant communications remain difficult for patients and caregivers to understand. Poor health literacy can negatively affect informed decision-making, recruitment, retention, and participant engagement. This interactive session will provide attendees with a practical framework for developing, evaluating, and maintaining health-literate research materials by incorporating plain language, stakeholder engagement, and user-centered design throughout the process. The session will cover focus groups, usability testing, iterative review cycles, and approaches for assessing both technical accuracy and participant understanding. Attendees will also explore best practices for culturally and linguistically appropriate translations and engage in hands-on activities to evaluate and redesign research materials using health literacy principles and accessibility tools. They will leave with practical templates, checklists, and usability testing resources that can be immediately applied within their research programs.

CEU: 1.0 ACRP

Speaker:

• Aimee Pehrson, PhD, MHA, MPH, Health Research/Evaluation Consultant, Verum Health Sciences, LLC

Connect with colleagues, meet new faces, and mingle with 50+ leading-edge organizations and suppliers helping move clinical research forward.

Enjoy a beverage, light hors d’oeuvres, and the energy of the Expo Hall as you connect with peers and discover what’s happening across the industry.

Connect with the ACRP and Academy Boards of Trustees, Committees and Council members, Fellows, Certification Milestone Recipients, and other key supporters at this reception to thank you for your contributions to the organization.

This event is sponsored by