Join us for breakfast while connecting with 100+ leading-edge organizations and suppliers helping you get better results in clinical research.
When you arrive in New Orleans, make your way to the registration area to receive your conference badge and essential materials, ensuring you're fully equipped for four days of engaging education sessions and valuable networking experiences.
Signature Series Session
Artificial Intelligence (AI) is on the loose, but don't panic – instead, join us for a panel discussion that offers a scenic tour of the work of AI. We will start the journey with an introduction to the basics of what AI is and how it is being implemented into clinical research. Our panelists will then steer us toward critical talking points regarding the responsible use of AI and how we can navigate this journey together as we move to embrace its many applications in clinical research.
Objectives:
Describe the components of AI
Explain the current role of AI in clinical research
Discuss responsible use of AI
Discuss how the clinical research industry (including patients) can benefit from AI now and in the future.
CEU: 1.00 ACRP
Speakers:
Ryan Brown, Regional Vice President, Sales - Trial Landscape, H1
Pamela Tenaerts, MD, Chief Scientific Officer, Medable
David Vulcano, LCSW, MBA, CIP, RAC, VP Clinical Research Compliance & Integrity, HCA Healthcare
We will examine the evolution of the clinical research coordinator (CRC) role, focusing on the impacts of traditional job descriptions and requirements assigned to the role. We will also look at how the mindset resulting in a “gatekeeping” approach for hiring impacts potential new CRCs' interest in and recruitment/retention for the role. Comparing the traditional requirements of 2-3+ years experience in the field for CRC roles puts many qualified candidates out of the running when they have transferable skills. This panel will provide a collaborative platform for discussions and dialogue regarding past, present, and future practices, and responsibilities of the next generation of CRCs. A primary focus for this session will be examining the changing research landscape and encouraging reflection on the impacts of recent trends on sites/studies. Through panel members sharing experiences and attendees engaging throughout the session, participants will gain insights into the value of more inclusive hiring practices and strategies to promote diversity in the field.
CEU: 1.00 ACRP
Speakers:
Micki Le, Director or CRCs and PMs, SiteBridge Research
Lauren Stockwell, Content & Engagement Manager, Society for Clinical Research Sites
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When study teams at research sites join a multi-site study as a "relying site" under the watch of a single institutional review board (sIRB) for the overall study, they must go through several steps to prepare their submission to the sIRB for approval of their site. However, different relying sites do not always follow the same process for facilitating sIRB approval. This inconsistency makes it challenging for lead principal investigators and their lead study teams to efficiently coordinate site start-up approvals. A standardized process would be very helpful, highlighting the need for harmonized workflows across sites. The goal of this session is to present a model site implementation process for relying site study teams to use to direct the process and harmonize it across sites. The model was developed in conjunction with study teams experienced in the sIRB process as lead and relying sites.
CEU: 1.00 ACRP
Speakers:
Polly Goodman, CIP, Senior Associate Director, Regulatory Affairs Operations, SMART IRB
Jeremy Lavigne, MA, CIP, Senior SMART IRB Officer, Harvard Catalyst | The Harvard Clinical and Translational Science Center Harvard Medical School
Michael Linke, PhD, Adjunct Professor, University of Cincinnati/Stroke Net
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Conducting clinical trials on a global scale presents unique challenges, including navigating dynamic regulatory requirements and diverse landscapes. This session will examine The U.S. Food and Drug Administration's 21 CFR Part 11 from the Code of Federal Regulations and its European Union counterpart, EudraLex Annex 11, to uncover the foundational requirements for utilizing electronic records and electronic signatures in clinical trials conducted within these regions.
CEU: 1.00 ACRP
Speaker:
Sara Saunders, MHA, CCRP, Sr. Manager, Regulatory Affairs, Florence Healthcare
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Over the next four years, the U.S. Food and Drug Administration (FDA) will phase out enforcement discretion for laboratory developed tests. These tests will be regulated as in vitro diagnostic (IVD) medical devices subject to FDA risk classification and premarket requirements for clearance/approval. Likely, there will be an increase in IVD pivotal clinical investigations. This session will look at the various IVD study designs as they relate to test users and use environments, and will highlight site considerations for readiness to support these kinds of clinical studies.
CEU: 1.00 ACRP
Speaker:
Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Data form the cornerstone of efforts to address health disparities and advance health equity across the globe. In the United States, Medicare and Medicaid collect and publicly disclose race, ethnicity, and socio-economic characteristics to address health disparities and identify underserved communities. In Europe, healthcare systems and policies vary significantly across countries. While some European countries collect similar data as in the U.S., other countries collect and share no or only limited data due to concerns about discrimination, individual privacy, or historical sensitivities. Despite the limitations, there is still a broad range of high-quality data which can be consolidated, standardized, and visualized to support streamlined diversity and site identification strategies. We’ll take a deep dive into the hurdles and complexities of diversity data collection and the efforts needed for standardization of data, explore the potential barriers and factors that explain the gaps in current data strategies, and discuss data-driven approaches for more diverse clinical research.
CEU: 1.00 ACRP
Speaker:
Elke Ydens, Associate Director of Business Solutions, Anju Software
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National strategic policy in England is to expand the diversity of clinical trial participants, bringing research opportunities to communities most in need. Our hospital has worked to commission wide-ranging dataset visualizations, to pinpoint which specific areas of the country have the greatest disease burden, and so may be prime candidates for clinical trial site selection. We have integrated assessment of cancer incidence, prevalence, and mortality--in addition to demographic data--to create a data-driven approach to site identification and selection, rather than using more traditional performance metrics or simply prior experience and relationships. We aim for an England where no cancer patient is left behind without access to research, and where our clinical trials recruit rapidly to time and target whilst bringing immediate patient benefit to those most in need.
CEU: 1.00 ACRP
Speaker:
Mark Brandon-Grove, Head of Clinical Research Performance & Quality, The Royal Marsden NHS Foundation Trust
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This interactive session is intended for experienced professionals who deal with complex clinical trials issues focused on during U.S. Food and Drug Administration (FDA) audits and inspections, need to understand the latest developments, and can contribute their own experiences. Presenters will cover important Good Clinical Practice topics to prepare for audits and regulatory inspections and for addressing any resulting observations. The presentation will be followed with hands-on activities to create corrective and preventive action (CAPA) plans, utilizing root cause analysis procedures to address FDA citations in Warning Letters, Notices of Initiation of Disqualification Proceedings and Opportunity to Explain, and Form 483s (Notice of Inspectional Observations). Tools will be provided and participants will work in groups. The session provides an opportunity to collaboratively hone skills in problem solving and root cause analysis, resulting in effective CAPA plans.
CEU: 1.00 ACRP
Speakers:
Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, Independent Consultant, Assured of Quality Consulting & Training
Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer
The Centers for Disease Control and Prevention defines health equity as “the state in which everyone has a fair and just opportunity to achieve their highest level of health.” The clinical trials industry stands at a precipice, buffeted by community and regulatory calls for diversity action plans and headlines that highlight health disparity statistics. With great opportunity to innovate and streamline clinical trial processes that have historically and currently preclude diverse participation and representation, we are called to answer core questions related to the role of health equity in clinical trial design. Whether observational or experimental, the clinical trials industry must realign its “why” with and through community engagement by being responsive to participation barriers that intersect with multiple levels of challenges posed by social drivers of health and cultural norms.
CEU: 1.00 ACRP
Speaker:
Gelise Thomas, JD, MS, Founder and CEO, HEIR Ventures LLC
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How can sites decrease the most common non-compliance issues cited in regulatory inspections? The types and frequency of these findings have not changed significantly in the past decade. With increasing complexity in research protocols, quality remains a concern to regulatory authorities. While monitors play a significant role in ensuring site performance and compliance, U.S. Food and Drug Administration notices place the onus on site personnel. In this presentation, we will highlight areas of deficiencies seen over many years at investigator sites. We will also discuss common inspection findings and how to spot the pitfalls that sites need to address in order to ensure compliance in conduct, performance, and overall execution of clinical trials.
CEU: 1.00 ACRP
Speakers:
Suheila Abdul-Karrim, CCRA, FACRP, ACRP-MDP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant
Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC , Independent Clinical Research Professional, Medical Writer, Consultant
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Clinical research represents a robust profession with many enticing factors: advancement opportunities, diverse skill application, good pay, and the potential to play a significant role in improving healthcare. However, development of a sustainable, diverse, and talented workforce has several known barriers. Among these are limited awareness of clinical research career and training opportunities compounded by a persistent catch-22 requiring prior work experience for entry-level positions. Here we explore a few of the innovative new models that are tackling these critical issues. From clinical research competency training in high schools, equity-focused internships, employer-based apprenticeship programs, and city-site partnerships to support economic development through CRP training and placement, employers and educators are using creativity and collaboration to reduce roadblocks and forge new pathways into the clinical research workforce.
CEU: 1.00 ACRP
Speakers:
Stephanie Freel, PhD, PMP, Director, Clinical Research Operations, Education & Outreach, Duke University
Olga Kishchenko, CCRP, Education Program Manager, UC Davis Health
Leshon Matthews, AAS Clinical Trial Research Associate, Clinical Research Specialist Senior, Duke University
Sharleen Traynor, PhD, MPH, Director, Clinical Trials Research Associate Program, Durham Technical Community College
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Effective data governance is crucial for organizations involved in clinical research for drug and medical device development. However, the implications of evolving European Union (EU) laws, such as the General Data Protection Regulation (GDPR), Clinical Trials Regulation (CTR), Medical Device Regulation (MDR), Artificial Intelligence (Ai) Act, and Data Act, bring many new challenges. This session will explore some of the key data privacy compliance challenges for contract research organizations and sponsors, sharing real-world business examples and insights. The implications of the CTR, MDR, AI Act, and other jurisdictional regulations will be explored, focusing on the complexities of processing EU/United Kingdom trial participants’ data. Guidance on when to appoint a data privacy officer and representative will also be provided. Attendees will gain a deeper understanding of how to identify the challenges posed by privacy laws, particularly the EU’s GDPR, and recognize what is required for effective data governance under the CTR and MDR.
CEU: 1.00 ACRP
Speaker:
Rob Masson, CEO, The DPO, Centre
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Clinical research is one of many industries being disrupted by rapid technological advancements, and while the number of vendors today is overwhelming, most agree that the overall tech experience remains poor (especially at the site level). With a need for tech transformation in mind, the audience will be challenged to consider what we can learn from disruptive technology that we’ve experienced as consumers ourselves; how real estate, marketing, eCommerce, and other arenas have evolved with the goal of an improved consumer experience as their driving force; and how we should be optimizing based on where other industries have found success. This interactive session will challenge all attendees, from novice to expert, to intentionally evolve our own industry based on what others have already learned.
CEU: 1.00 ACRP
Speaker:
Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems
This session will focus on helping attendees understand what undue inducement of human research subjects is and how to reconcile this with fair compensation for participating in clinical trials. Guidance documents regarding subject payment will be examined, as will the topics of how undue inducement might occur indirectly, and the delicate ethical balance between compensation as a tool for diversification and exploitation of vulnerable subject populations.
CEU: 1.00 ACRP
Speaker:
Steffi Newell, MS, RN, OCN, CCRC, Clinical Research Nurse, Rush Medical Center
Watch a Sneak Peek into the Session Content:
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
The overall focus and goal of the session is to support attendees’ knowledge and skills on the key elements for building a successful investigator-initiated clinical trial protocol, with a specific focus on developing clinical trials in oncology. Participants will gain an understanding of how to effectively move research ideas from the bench to the bedside, beginning with the design of a feasibility assessment and feasibility review. The development of early protocol documents that are used to secure study drugs/devices and funding will be discussed, along with the planning strategies necessary for making the protocol as comprehensive and inclusive as possible (e.g., choosing entry criteria to enhance diversity and inclusiveness will be discussed).
CEU: 1.00 ACRP
Speaker:
Kimberly Bullock, PhD, Director, Protocol Development Team and Associate Professor of Research, University of Virginia
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Over the last two decades, the landscape of clinical research has transformed dramatically with increased staffing needs, largely due to the dynamic nature of the field and escalating regulatory demands. Many clinical research stakeholders have developed workforce programs to address challenges in hiring, recruitment, education, and maintenance of a skilled research team, ultimately enhancing the caliber of clinical research. Opportunities to attract top-tier clinical research personnel are abundant in unconventional environments. Members of this panel will recount the unique paths they traveled along from atypical professions to their current roles in clinical research. Utilizing their adaptable skills, they have successfully transitioned to this sector, contributing their extensive relevant experience. As we tackle the issues of hiring and keeping a dedicated workforce, it is advantageous to consider candidates from non-standard clinical research backgrounds.
CEU: 1.00 ACRP
Speakers:
Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine
Sherry Huber, Clinical Research Nurse Coordinator, Senior, Duke University School of Medicine
Using lessons learned from the implementation of the National Institutes of Health single institutional review board (IRB) mandate in 2018 and the Common Rule cooperative research provisions enacted in 2020, participants will explore how changes in the U.S. Food and Drug Administration (FDA) regulations requiring single IRB review, as proposed in 2022, would impact how clinical researchers get IRB approval for their studies. Building on the processes already in place nationally to have IRB review conducted by a single IRB, this session will discuss how the narrower scope of the FDA’s proposed single IRB requirements will necessitate that clinical research teams work more closely with their local IRBs and possibly the FDA prior to proposal submission. Participants will also learn more about the specific decision points required when considering whether the proposed FDA single IRB requirement applies to proposals.
CEU: 1.00 ACRP
Speaker:
Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Watch a Sneak Peek into the Session Content:
Is the crowded daily work routine at your study site reaching overwhelming proportions? Does it feel as if you have too many things to do and not enough hours in the day? You're not alone. We will discuss how to find support in one another in the workplace when our caseloads can seem overwhelming, share some valuable tools we have used to help us stay organized when we are responsible for multiple studies, and offer some tips and tricks to make onboarding new coordinators a breeze, especially when you feel like you don’t have the time! Teamwork makes the dream work. Join us for a great look at how an academic medical center handles a variety of studies and what we have found helps make us successful.
CEU: 1.00 ACRP
Speakers:
Hannah Culpepper, CCRC, Clinical Research Coordinator, Medical University of South Carolina
Stephanie Schorr, CCRC, Clinical Research Coordinator, Medical University of South Carolina
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Patient recruitment remains a significant challenge in our industry, often exacerbated by outdated U.S. Food and Drug Adinistration guidelines. Despite these constraints, there are ways to improve recruitment through better advertising practices. This panel brings together perspectives from sponsors/contract research organizations (CROs), institutional review boards (IRBs), and sites to discuss best practices within their organizations and how to form effective, mutually beneficial partnerships. We will focus on how sites and sponsors/CROs can implement winning strategies in patient recruitment advertising that also meet IRB review expectations. Each organization will offer actionable insights aimed at enhancing their processes to improve recruitment outcomes.
CEU: 1.00 ACRP
Speakers:
Meghan Joseph, Site Engagement, Patient Recruitment & Retention, Moderna
Jason Rush, BS, CIP, Senior Director, Regulatory, Advarra
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Kayra Velez, Senior Marketing Specialist, Centricity Research
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This session explores the current state of available clinical research workload tools and compares several similar adaptations of a specific tool for tracking productivity at various types of research programs. The focal model presented offers great flexibility in both oncology and non-oncology settings, as it allows for continuity of care amongst study coordinators for their study participants. The metrics presented can be used to justify new and existing employees for research programs running clinical trials predominately on the high end of the acuity continuum. Further, the metrics can be used to increase funding for additional coordinator and support staffing while improving study coordinator job satisfaction and retention at sites. This allows sites to achieve their enrollment goals and promote progress in their clinical research practice. In the wake of such improvements, research programs can expect more funding opportunities and greater success.
CEU: 1.00 ACRP
Speaker:
Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
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Research sites often grapple with the complexities of disbursing participant stipends and reimbursements. These challenges stem from unclear stakeholder roles, diverse payment methods (e.g., reloadable cards, cash, checks), federal tax rules, guardianship issues, and ethical considerations for providing payments for clinical trial participation. To address these hurdles, this session will explore creative approaches in this arena, including diverse methods for handling reimbursements, sponsor budget negotiation tactics, and technology systems for efficient and compliant management. The session will emphasize the importance of adhering to federal regulations while considering institutional organizational structures such as centralized or decentralized management of payments and reimbursements. The session will also give attendees the tools and strategies to determine the best solution for their organization.
CEU: 1.00 ACRP
Speakers:
Samantha Herbst, Manager, Huron Consulting Group
Shreya Singh, Senior Associate, Huron Consulting Group
Watch a Sneak Peek into the Session Content:
In the world of research and development, we often think about new and emerging technologies, cutting-edge ideas, and innovative approaches. What if we could also strengthen the foundations by developing core competencies? The goal of this presentation is to highlight the importance of establishing and maintaining a healthy relationship between sponsors and research sites. This relationship highly relies on the competencies of the clinical research associate (CRA) to create and nurture this connection whatever the situation is (database lock, recurring issues/deviations, late sponsor payments, etc.). The presentation will focus on key strategies for maintaining effective communication and addressing common challenges. By promoting mutual respect and understanding, the CRA can ensure that both sponsors and sites work harmoniously toward common objectives. Emphasis will be placed on practical tips and real-world examples, exploring the Dos and Don’ts, important soft skills, and management of difficult conversations--ultimately aiming to enhance the effectiveness of clinical trials through strong and cooperative relationships.
CEU: 1.00 ACRP
Speakers:
Amine Sehboub, BSc, PgD, Pharm, Clinical Research Associate, Syneos Health
Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
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In this session, we will explore the often-overlooked financial and operational costs associated with implementing diversity and inclusion (D&I) practices in clinical research, and practical strategies to mitigate these costs. While the benefits of D&I are widely recognized, understanding and addressing the hidden costs can help organizations create more effective and sustainable strategies. By enhancing their competencies and skills in this area, attendees will be better equipped to implement effective and sustainable D&I practices in their organizations.
CEU: 1.00 ACRP
Speaker:
Mitch Hilbe, CEO & Co-Founder, DiversiTrials
Clinical research professional shortages, high turnover rates, and an increasingly competitive job market contribute to negatively impact the conduct and success of clinical research studies. Employing individual retention conversations to improve and foster retention is one strategy in addressing this issue. These conversations empower managers/leaders in addressing areas of concern impacting an organization’s workforce while building transparency and trust. Attendees will learn the benefits and gain practical skills in preparing for, participating in, and conducting individual retention conversations, focusing on creating a positive atmosphere, asking probing questions, actively listening, and developing action plans based on conversation outcomes. Participants will leave with strategies for continuous follow-up and ongoing professional development, ensuring a sustained positive impact on employee satisfaction and retention. Results from pilot study will be discussed.
CEU: 1.00 ACRP
Speaker:
Stephanie Freel, PhD, PMP, Director, Clinical Research Operations, Education & Outreach, Duke University
Lindsay Hanes, BS, CCRC, Clinical Research Manager, The Ohio State University Medical Center
Shirley Helm, MS, CCRP, Senior Administrator for Network Capacity and Workforce Strategies, Virginia Commonwealth University
Drop-in for this quick 30-minute "small talk" offering insightful and practical tips from your ACRP peers.
This will be a casual setting where you can learn from—and connect with—your colleagues.
This session does NOT offer ACRP Contact Hours.
Additional Small Talk Sessions:
Small Talk—Patient Recruitment- Friday, April 25, 11:30 AM - 12:00 PM
Small Talk—Budgeting Tips for the Future - Friday, April 25, 4:30 - 5:00 PM
Small Talk—Crafting Your Clinical Trial Diversity Plans - Saturday, April 26, 4:30 - 5:00 PM
Maintaining optimal staffing levels to meet the dynamic nature of the clinical research environment effectively and efficiently has significant operational, financial, and compliance implications. Managing appropriate staffing levels across centralized offices requires communication, access to data, defined metrics, and an understanding of institutional processes. There are multiple mechanisms, tools, and resources to determine appropriate staffing levels for business roles to manage your clinical research portfolio. During this panel discussion, we will address various institutional methodologies for calculating full-time equivalent (FTE) needs and the data required to make informed decisions. This will help attendees identify opportunities for improving their infrastructure by exploring optimum staffing levels by task/function to promote quality research, meet sponsor expectations, and enhance workplace satisfaction levels in every role. We will also explore approaches to plan for growth and project future FTE needs.
CEU: 1.00 ACRP
Speakers:
Mindy Muenich, Senior Director, Huron Consulting Group
Shannen Nelson, Executive Director, Clinical Research Operations, Children’s Hospital Los Angeles
Stephanie Pabst, Assistant Vice President, Sponsored Research Services, Cincinnati Children’s Hospital Medical Center
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This session will describe the current state of clinical evidence planning for medical devices with respect to regulatory submissions (with emphasis on the expectations of the U.S. Food and Drug Administration and the European Union Commission) and broader business needs (e.g., reimbursement, support of claims). A description with specific examples of implementation of an integrated clinical evidence strategy and deliverables within medical device research and development (R&D) will be shared. Benefits and challenges encountered with clinical evidence planning and regulatory submissions for medical devices used in oncology settings will also be shared. Specific action points for organizations looking to build an integrated evidence strategy will be described and discussed.
CEU: 1.00 ACRP
Speaker:
Regina Fulkerson, PhD, Director, Clinical Evidence Planning & Evaluations, Varian Medical Systems
In this session, we will look at the incorporation of international healthcare professionals into study sites with an emphasis on the importance of cultural competence in clinical research settings, including consideration of how the lack of it can compromise patient screening and enrollment. We will also review common misconceptions about cultural competence and provide examples of how to address improving its strength among individuals and organization-wide, and tips for enhancing its applications at the site level.
CEU: 1.00 ACRP
Speakers:
Judy Galindo, CCRC, Executive Director, Sun Valley Research Center
Bernardo Ng, MD, Medical Director, Sun Valley Research Center
Victor Samperio, MD, Research Director, Sun Valley Research Center
