The implementation of artificial intelligence (AI) in the clinical research space has happened at such a rapid pace that many are left asking a fundamental question: How do we know if this thing is working the way we intended? When pressed, AI vendors rarely provide error rate data or any delineation between the root causes of failure. That absence of accountability is precisely where quality professionals need to step in. AI might be new, but basic research principles still apply.

Geared toward research site staff who are implementing generative AI for source records and sponsor staff using AI to support database and protocol development, this presentation borrows directly from medical device quality methodology to build internal AI quality assurance programs. Most current quality standards were not written with AI in mind; thus, quality assurance of AI systems does not require a novel approach, it requires research.

CEU: 1.0 ACRP

Speaker:

• Michele LaBadie, ACRP - CP, MDP, PM, Clinical Trial Manager, Shoulder Innovations

Organizations involved in the conduct of clinical research lose experienced professionals at rates that compromise trial quality, inflate costs, and slow start-up. Yet most workforce interventions arrive too late, after the damage is done. This session challenges a foundational assumption: that talent management is a human resources function. It is not. It is a clinical operations function, and the decisions made before a hire, during onboarding, and in the first 90 days of performance management determine whether a team delivers or deteriorates.

Drawing on real-world case studies from contract research organization and sponsor environments, this session presents a practical, two-question performance framework that replaces analysis paralysis with actionable leadership decisions. Attendees will leave with concrete tools to reduce attrition, improve team stability, and connect staffing decisions directly to operational outcomes, including budget adherence, enrollment timelines, and scope control.

CEU: 1.0 ACRP

Speaker:

• Rend Williams, Founder and President, Foresight Business Consulting

Ready to take the next step in your clinical research career? Join this expert panel of ACRP Certified professionals—leaders who’ve served on the Academy Board, committees, as item writers, and more—to gain insider knowledge on achieving your certification.

They’ll share their personal journeys and practical strategies for success, from navigating the application process to preparing for the exam. Discover what to expect during eligibility review, explore testing options, and learn proven study tips that can help you earn the most reputable credentials in the clinical research industry. ACRP Certification goes beyond the letters—learn how it can be a catalyst for impact, opportunity, and career growth.

Please note that this session will not cover exam content. If you have questions regarding your individual certification journey, please talk to the staff at the ACRP booth in the Expo Hall.

This session does not provide ACRP Contact Hours.

Speaker:

• Jen Milam, CAE, ICE-CCP, Certification Manager, ACRP

This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings. Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidances, International Council for Harmonization guidelines, and more targeting ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for stakeholders across the entire clinical research enterprise.

CEU: 1.0 ACRP

Speaker:

• David Vulcano, CEO, ACRP

Clinical research depends on well-informed, trusting communities, yet barriers such as limited awareness, health literacy gaps, historical mistrust, and cultural disconnects prevent meaningful engagement. Given their unique position, community health workers (CHWs) have the potential to increase awareness and comprehension of clinical research in communities that have historically faced challenges in accessing research opportunities.

This session will share lessons learned from initiatives that equip CHWs with the knowledge, tools, and resources to facilitate discussions about clinical research as the presenters explore practical strategies that foster trust in research through CHW engagement.

Attendees will gain actionable insights for partnering with trusted community voices, improving research communication efforts, and building sustained community relationships that support long-term trust, informed decision-making, and representative research participation.

CEU: 1.0 ACRP

Speakers:

• Rebecca Hayes, MD, MEHP, Director of Research, Chief Medical Officer of Carolina Medical Home Network Medicare Shared Savings Program Accountable Care Organization, North Carolina Community Health Center Association

• Korrey Monroe, MPH, Research Program Manager, North Carolina Community Health Center Association

• Perla Nunes, BS, Community Outreach and Bilingual Clinical Research Dedicated, Engaged & Impactful Thought Leader, Perla Nunes Consulting

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.