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.
Join us for breakfast while connecting with 100+ leading-edge organizations and suppliers helping you get better results in clinical research.
Join us in the Expo Hall from 8:00 AM - 2:00 PM and 4:30 - 6:00 PM for networking with exhibitors and your clinical research colleagues.
Breakfast will be served in the Expo Hall from 8:00 - 9:00 AM, and the Networking Reception will be held from 4:30 - 6:00 PM.
Signature Series Session
ICH E6 changes are upon us. Are you ready to implement new expectations for Good Clinical Practice (GCP) and a flexible framework for clinical trial design and conduct? Please join us for a panel discussion on the principles described within ICH E6(R3), the changes from ICH E6(R2), the implications for GCP, considerations for implementation, and insights on how we as an industry can think through flexible design in a quality-minded environment. This is a session you will not want to miss.
CEU: 1.00 ACRP
Speaker:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
The assurance of study subjects' privacy and confidentiality is fundamental to the enrollment of participants in clinical research. At the same time, the number of datapoints collected and commodified by the commercial world on each individual has increased exponentially. The potential overlap or convergence of these datastreams, whether intentional or inadvertent, threatens the promise of privacy. This session will explore the range and means of data collected in the pursuit of human research and the limits of protections possible in today's digital world.
CEU: 1.00 ACRP
Speaker:
Robert Romanchuk, CIP, Chairperson, Univo IRB, Univo IRB
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.
Your patient recruitment engine is the machine that fuels your site's success. Regardless of your wins or losses, every site wants to improve and add efficiency to its recruiting process. Chances are, a lot of what you're already doing is right, but there seems to be something new every day that clinicians can't resist seeking--the next "silver bullet" for marketing and recruiting. It's easy to feel you're behind in the space. It's easy to think you're over- or under-invested. It's easy to ponder that others are finding patients you're not. This session is designed to ease those fears. Find out about the things you think you might be missing. We'll discuss the media options sites are using, spend some time on the new things you keep hearing about, and give you the tactics to evaluate your recruiting operation. Then you can decide where best to allocate resources and grow.
CEU: 1.00 ACRP
Speaker:
Mark Metzner, Senior Manager, Patient Recruiting & Feasibility, CTI Clinical Trial Services, Inc.
This session will help attendees learn how project management techniques can streamline the clinical study start-up process. Discover essential skills like time management, risk assessment, and effective communication, and explore practical tools for strengthening them. Through interactive activities, attendees will be able to develop a robust project plan, manage resources efficiently, and mitigate risks. Attendees will also be able to enhance their ability to handle complexities and minimize delays, ensuring timely study initiation. This session is ideal for clinical research professionals aiming to improve start-up efficiency, as it will offer practical takeaways, including templates and checklists, to apply immediately to their work.
CEU: 1.00 ACRP
Speaker:
Megan Lamberti, Vice President of Clinical and Regulatory Affairs, Nilo Medical Consulting Group
Watch a Sneak Peek into the Session Content:
Advancements in precision oncology have led to the development of life-changing, novel treatment modalities in the clinical trial setting. However, significant disparities persist in who benefits from these treatments. Public health has established core principles to ensure equitable access to care for all. How can the clinical trial landscape benefit by applying these public health principles to ensure equitable access to clinical trials? This session will explore the role of social determinants of health and provide a foundational framework for integrating community-based participatory research (CBPR) into current research projects. Participants will learn strategies to improve patient engagement and outcomes through CBPR. Attendees will leave with practical examples and methods to measure the success of their health equity initiatives in clinical research.
CEU: 1.00 ACRP
Speaker:
Rochelle Williams-Belizaire, Director, Clinical Research Collaborations, Mirati Therapeutics
Watch a Sneak Peek into the Session Content:
We are experiencing serious shortfalls in the number of clinical research physicians (principal investigators) needed to keep the enterprise healthy, in part due to aging populations and to the aftereffects of restrictions and burnout from pandemic conditions. It is estimated that less than 5% of U.S. physicians are participating in clinical research at any given time. Is there a sustainable path to attracting and retaining new and returning physicians for conducting clinical studies? With approximately 70,000 clinical studies ongoing or planned, and 35% being U.S.-only, the challenge is to create a collective approach addressing the gap ahead. Sponsors, contract research organizations, site networks, and medical associations realized during the worst days of COVID-19 that collective minds create solutions. Engaging/involving more "research naïve" physicians is a key to success for stakeholders everywhere. Understanding what these physicians need is important. This panel will include physicians who are new to the principal investigator role. Why did they add clinical research to their patient-care services? What have they learned? Why have they continued in clinical research? Are their communities showing greater interest? What are their enrolled patients sharing with them about their experiences as participants?
CEU: 1.00 ACRP
Speakers:
Edwin Burkett, MD, Chief Medical Officer, Alliance Medical Ministry
Amir Herman, DO, Medical Director, East Northport Medical Care
Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc
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.
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—Budgeting Tips for the Future - Friday, April 25, 4:30 - 5:00 PM
Small Talk—Investigator Engagement - Saturday, April 26, 2:00 - 2:30 PM
Small Talk—Crafting Your Clinical Trial Diversity Plans - Saturday, April 26, 4:30 - 5:00 PM
Professionals in any position and at any level can be empowered to make positive, impactful changes in a clinical research environment. This session will focus on techniques to initiate and sustain targeted improvements in the efficiency and effectiveness of research and research-adjacent processes. Strategies include systematic problem solving, process mapping, application of lean philosophies, and engagement of stakeholders. The goal of the session is to make change and improvement accessible to all staff, highlight concrete tools and techniques that can be applied to virtually any scenario, and empower attendees to start or re-ignite their own quality improvement journey.
CEU: 1.00 ACRP
Speaker:
Eric Rockefeller, Chief of Quality Assurance, Department of Veterans Affairs - Veterans Health Administration
Watch a Sneak Peek into the Session Content:
Artificial intelligence (AI) and machine learning (ML) technologies are transforming healthcare delivery. Understanding the regulatory framework for study AI/ML utility, accuracy, efficacy, and reproducibility is key to the research process prior to its use in patient diagnosis and care. This is a cutting-edge topic upon which many new federal guidance documents have focused. It is often misunderstood by sponsors, sites, and investigators that if AI/ML is used for diagnosis, the technology it is FDA regulated. Operationally, the inclusion or exclusion of AI/ML findings into the electronic health record is poorly understood, although it is analogous to the 21 CFR 812 Investigational Device Exemption or 510 K pathway used for new laboratory testing procedures.
CEU: 1.00 ACRP
Speakers:
Betty Donoval, Director, Research & Regulatory Affairs, Cook County Health
Pamela Gonzalez, Manager Research Consultant, Huron LLC
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.
This session aims to introduce a strategic approach to workforce development that is rooted in implementation science to support clinical research quality operations, sustainability, and growth. The methodology will demonstrate the strategic integration of the diverse array of educational resources now widely available in the clinical research sector into a staged approach for impactful workforce upskilling. This spans from individual staff development to organizational governance, extending to inter-organizational learning networks. At its core, the upskilling framework calls for aligning workforce development with organizational goals, ensuring education efforts are not only relevant but strategically positioned for transformative change. This adaptability, synchronized with each organization's unique capabilities and maturity, cultivates a culture of continuous learning, stimulating growth and advancing capabilities. This approach offers a flexible solution for the evolving workforce needs in our diverse clinical research landscape and the dynamic challenges of clinical research programs.
CEU: 1.00 ACRP
Speaker:
Thobe Mthethwa-Pitt, Senior TrialHub Clinical Trials Education Manager, Alfred Health
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Failure to understand and implement a comprehensive research billing compliance program can result in monetary penalties, close scrutiny from the U.S. Department of Health and Human Services' Office of Inspector General, and loss of reputation to a research institution. Institutions participating in clinical trials must understand the risks. Additionally, they need the knowledge and skills to accurately perform coverage analysis and manage charges based on that analysis. Finally, institutions need tools for conducting internal audits to ensure all processes are followed correctly. In this master class, participants will learn the “why” of having a comprehensive clinical research billing compliance program and can practice their coverage analysis and auditing skills through hands-on activities.
CEU: 1.00 ACRP
Speaker:
Shanna Ford, MHA, Research Office Senior Associate, Huron Consulting Group
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.
You can learn about the many facets of clinical research and have fun at the same time in this fast-paced game show format. Watch teams pit their knowledge of clinical research against each other until a winner emerges. Audience members will be encouraged to play along as their colleagues are challenged with questions that vary in complexity and subject. Questions may require teams to recall core principles of ICH Good Clinical Practice, eClinical technology, or the basics of informed consent, as examples.
CEU: 1.00 ACRP
Speakers:
Elisa Cascade, MBA, Chief Product Officer , Advarra
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Signature Series Keynote Session
Artist, resilience expert, burn survivor, entrepreneur, and inspirational storyteller, Allison Massari knows first-hand the healing power of compassion. In this inspiring session, hear how you can be the remedy with simple acts of kindness that take seconds. Leave with actionable insights and ways to incorporate compassionate care into your clinical research practice.
Speaker:
Allison Massari, Interdisciplinary Artist, Executive Coach, Entrepreneur
This session focuses on developing essential skills for effective study and site management. Participants will gain practical knowledge in key areas, including protocol implementation, regulatory compliance, and patient recruitment. The goal is to enhance coordinators' competency through hands-on training and real-world scenarios. Key topics include optimizing site workflows, managing study timelines, and ensuring data integrity. Attendees will leave with actionable strategies for improving site performance and study outcomes, making them invaluable assets to their research teams.
CEU: 1.00 ACRP
Speaker:
Tia Warrick, DHSc, MPH, CCRA, ACRP-PM, Chief Executive Officer, Lesous Consulting LLC
Watch a Sneak Peek into the Session Content:
Applying for institutional review board (IRB) review can be a daunting process when you don't understand how these boards function or why their decisions are so important. What application do I use for my study? What's the big deal about consent forms? How long will review take? Why do similar-sounding studies earn different decisions? The IRB review process can seem quite opaque initially; however, most IRBs use similar processes and a lot happens behind the scenes to bring order out of potential chaos. In this session, you will learn the base rules and regulations IRBs follow when reviewing applications, the possible outcomes following review, and the general flow most IRBs use when reviewing applications.
CEU: 1.00 ACRP
Speaker:
Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
Watch a Sneak Peek into the Session Content:
In clinical research, the deaf community continues to be a chronically underserved group. Ensuring accessibility for deaf patients can be a challenge without proper guidance. There are many paths to accessibility, including written communication, computer-assisted real-time transcription, use of interpreters, and providers who know American Sign Language, to name a few. This session will focus on strategies to improve accessibility for deaf patients at study sites. Attendees will learn how to choose the right communication method for their patients, interact with interpreters, and incorporate these expenses into the clinical trial budget. This session will challenge attendees to further their understanding of the deaf community and promote advocacy at their sites.
CEU: 1.00 ACRP
Speakers:
Krista Kachnik, BS, Clinical Research Coordinator, The Spine Network
Marcus Stone, PhD, ACRP-CP, Principal, The Spine Network
Watch a Sneak Peek into the Session Content:
An electronic data capture (EDC) system is software that’s used to electronically collect, manage, store, and export data for the clinical investigations which are critical to support safety and effectiveness claims for drugs, devices, and diagnostic tests. Most EDC systems can be customized to ensure data collection matches the product performance criteria, population characteristics, and statistical analysis plan for a product regulatory submission. This session will describe best practices and pitfalls to avoid when ensuring an EDC system is fit for each unique clinical investigation purpose. Let’s talk about the dos and don'ts and the collaborative sponsor/site/contract research organization approach to EDC validation to make sure we have a clean dataset with the most automated efficiencies and data mapping to scientific endpoints to achieve EDC that's fit for purpose every time.
CEU: 1.00 ACRP
Speaker:
Patricia Smith, Senior Clinical Data Manager, 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.
Drop-in for this quick 30-minute "small talk" offering insightful and practical tips from your ACRP peers. Clinical research sites will share their budgeting tips, including two new budget line items they've recently added and the line items they struggle to get approved by the Sponsor/CRO.
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—Investigator Engagement - Saturday, April 26, 2:00 - 2:30 PM
Small Talk—Crafting Your Clinical Trial Diversity Plans - Saturday, April 26, 4:30 - 5:00 PM
This presentation will consider the regulatory, operational, and ethical facets of collecting genetic information for clinical research. Topics covered will include regulations surrounding genetic testing and return of results; optimizing protocol design to facilitate specific genetic testing while reducing unnecessary collection; and considerations for biobanking, de-identification, and future research. Participants will leave this session with a robust view of research regulations, innovative ideas to incorporate into protocol design, and a deeper appreciation for patient privacy concerns.
CEU: 1.00 ACRP
Speaker:
Lauren Blizzard, Lead Associate, Clinical Research, ETRA
Watch a Sneak Peek into the Session Content:
Clinical research professionals are used to calling the shots, running the protocols, and making sure everything operates smoothly during trials. But have you ever wondered what it's like to be on the other side of the clipboard? This session turn the tables so that attendees can hear from seasoned professionals who have stepped into clinical research participant role. Join us for a lively discussion as our panelists share their experiences and insights, revealing how being a participant has shaped their approach to research.
CEU: 1.00 ACRP
Speakers:
Bishoy Anastasi, Senior Director, Clinical Research Finance & Strategy, UCLA School of Medicine
Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems
Meredith Fitz-Gerald, RN, MSN, Director-Clinical Research Support Program, The University of Alabama at Birmingham
Mark Marchant, MBA, MPH, CCRP, Executive Director-Clinical Trials Administrative Office, The University of Alabama at Birmingham
Brian Sevier, PhD, Chief Operations Officer-Yale Center for Clinical Investigation, Yale University
Laura Viera,, MS, CCRP, Director-Clinical Research Operations, University of North Carolina
Watch a Sneak Peek into the Session Content:
Numerous clinical trial failures are traced by the U.S. Food and Drug Administration back to inadequate oversight by principal investigators (PIs). This session delves into real-world examples of such failures, highlighting the threats posed to participant safety and trial integrity. We will explore key focus areas, including the qualifications of delegated individuals, adequacy of training, requirements for continuous supervision, and provisions for third-party oversight. Attendees will learn how to avoid common pitfalls and enhance PIs' knowledge to ensure trial success. Additionally, we will discuss the practical application of risk-based quality management, the ongoing debate on the necessity of monitoring, and the impact of training deficits. This session is essential for clinical research professionals aiming to support PIs and uphold the integrity of clinical trials.
CEU: 1.00 ACRP
Speakers:
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Kelly Cairns, MA BASc, APMR, CCRA, FACRP, Head, Quality Medicine, Boehringer Ingelheim Canada
Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Owner, Independent Consultant, Responsibility Research
Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC , Independent Clinical Research Professional, Medical Writer, Consultant
Watch a Sneak Peek into the Session Content:
This session will help attendees learn how project management techniques can streamline the clinical study start-up process. Discover essential skills like time management, risk assessment, and effective communication, and explore practical tools for strengthening them. Through interactive activities, attendees will be able to develop a robust project plan, manage resources efficiently, and mitigate risks. Attendees will also be able to enhance their ability to handle complexities and minimize delays, ensuring timely study initiation. This session is ideal for clinical research professionals aiming to improve start-up efficiency, as it will offer practical takeaways, including templates and checklists, to apply immediately to their work.
CEU: 1.00 ACRP
Speakers:
Tamika Harris, Clinical Operations Manager - Regulatory, Merck
Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck
Watch a Sneak Peek into the Session Content:
Effective patient recruitment and retention are vital for clinical trials and healthcare initiatives. Traditional methods often fail due to a lack of genuine representation and authenticity, leading to underrepresentation of minority groups and skewed research outcomes. To address this, recruitment strategies must prioritize authentic representation by understanding and respecting the cultural, social, and linguistic nuances of different communities. This includes collaborating with community leaders, using culturally sensitive communication, and employing diverse media channels that resonate with target populations. Authentic representation builds trust and fosters inclusion, encouraging participation and maintaining engagement throughout the study. It ensures research findings are more generalizable and reflective of the broader population. Prioritizing genuine representation enhances study validity, improves health outcomes, and promotes equity in medical research. Moving beyond the status quo and adopting inclusive, representative strategies is both a matter of fairness and a scientific necessity for advancing healthcare.
CEU: 1.00 ACRP
Speaker:
Tania Martin-Mercado, MS, MPH, Chief Executive Officer, Phronetik
Watch a Sneak Peek into the Session Content:
Connect with your colleagues and 100+ leading-edge organizations and suppliers helping you get better results in clinical research.
Relax and unwind with a beverage and light hors d'oeuvres in the Expo Hall.
Our industry struggles with inefficiencies in conducting clinical trials effectively and on time. While issues like poor communication between sponsors, contract research organizations, and sites, and even excessive reliance on technology, are often highlighted, the core issue lies in human behavior. The natural reluctance of individuals to embrace change (whether driven by fear or disinterest), coupled with leaders' inability to communicate and sustain changes effectively, hampers progress. This session will delve into how clinical research professionals across all roles can enhance their careers and drive industry-wide improvements by mastering change management and fostering acceptance. By learning to navigate and implement change effectively, professionals can significantly contribute to their organizations and the broader clinical research field.
CEU: 1.00 ACRP
Speaker:
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Watch a Sneak Peek into the Session Content:
