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
Join Dr. David Burrow from FDA's Center for Drug Evaluation and Research as he explores operational strategies for implementing Quality by Design and the integration of Risk Based Quality Management Systems into routine trial design and conduct. Dr. Burrow will build on the key themes discussed in his 2024 Signature Series presentation titled, “Reimagining Clinical Research: The Transformation of Trial Design & Conduct” and bring his own unique perspectives to the next stage of reimagining clinical research and removing barriers to innovation. Take away practical approaches to mitigating obstacles, advancing the shared interests of human subject protection, generating high quality evidence of safety and effectiveness, and enabling action through strategies to manage fear - both as an organization and as an individual.
Objectives:
Discuss key themes of Quality by Design, Critical to Quality factors, and Risk Based Quality Management Systems.
Advance shared understanding of the CDER Center for Clinical Trial Innovation (C3TI) and other FDA drug development programs.
Provide strategies to advance innovation and enhance quality while also minimizing fear of regulatory oversight.
CEU: 1.00 ACRP
Speaker:
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
The landscape of clinical trial design, conduct, and regulation continues to shift thanks to the rapid infusion of technology and an increased emphasis on inclusion and access. As a result, the U.S. Food and Drug Administration (FDA) and Congress are reevaluating their stances in a number of areas in order to further speed the path to healthcare innovation. However, these changes in policy can present operational challenges for sites and sponsors in the day-to-day management of trials and patient care. This session will run through the latest guidance changes and what they mean for sites and sponsors in 2025. Areas of focus will be the updated guidance on informed consent, diversity action plans, digital health technologies, decentralized clinical trials and Form FDA 1572 reform, use of real-world evidence, and changes to the FDA's Bioresearch Monitoring Program inspection processes. Additionally, the speakers will address the final ruling on taxing patient stipends, the Inflation Reduction Act, and the Food and Drug Omnibus Reform Act of 2022's mandate for innovation.
CEU: 1.00 ACRP
Speakers:
Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
Sophia McLeod, Sr. Director of Government Relations, Association of Clinical Research Organizations (ACRO)
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.
Community outreach remains the industry standard for patient recruitment in minoritized (and majority) communities. Defined as one-way communication, community outreach is often a transactional process that doesn’t typically leave room for bridging the gap between opportunity and community. While outreach may be necessary in some cases, we must begin to make a conscious shift toward engagement through true community partnerships for more equitable access and outcomes. This session is for those hoping to dive deep into community engagement planning and implementation for their organization. Attendees will come away with a new understanding of the pivotal role our communities play in shaping a more equitable and inclusive clinical trial landscape, and tools for deploying impactful and sustainable community engagement plans.
CEU: 1.00 ACRP
Speaker:
Ashley Moultrie, CCRP, Senior Director, DEI & Community Engagement, Javara
Watch a Sneak Peek into the Session Content:
It seems as if everyone has their own way of designing case report forms (CRFs), which for study coordinators can mean encountering new expectations (good, bad, or indifferent) from study to study as well as the same things (truly necessary or not) across many studies. But each time, there's a bit of copying and pasting happening, in hope that lessons learned from prior studies will guide the development of future CRF content. But what if you could have a fail-proof process to ensure that the first draft of a CRF had 95% of the critical variables needed? Find out how using a statistics-driven approach to reverse engineer report tables can simplify CRF design. Cut out the noise by removing onerous and non-applicable checklist variables and focusing on only adding analyzable fields that make every single variable practical. During this talk, a research coordinator-turned-clinical research associate will also provide insight into how they contribute to the review process to ensure flow at the site is taken into consideration.
CEU: 1.00 ACRP
Speakers:
Eleanor Goblirsch, Clinical Research Associate, Bright Research
Robin Solinksky, BS, VP, Technology & Innovation, Bright Research
Watch a Sneak Peek into the Session Content:
The future is here, and new technology available for investigational product (IP) management opens up a wide range of opportunities. In this session, we will provide an introduction to new IP temperature monitoring capabilities, cold chain innovation, digital automation, predictive analytics, and sustainable technologies that have the potential to enable enhanced quality and improve efficiency. We will also look at how new technologies at both the site and sponsor levels may support patient access to clinical trials and improve compliance with the tenets of ICH Good Clinical Practice.
CEU: 1.00 ACRP
Speakers:
Liza Hill, BS, ACRP-CP, ACRP-PM, Associate Director, Clinical Operations - Clinical Research Manager, Infectious Disease (US), Merck
Mary Williams, Associate Director, Clinical Operations, Merck
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.
Site-centric recruitment models powered by data and innovation are proving to be successful when two criteria are met--they reduce the burden on the site and they reach the patient closer to home. From "just-in-time" practices to decentralized clinical trials, this session will explore different recruitment models from the perspectives of experts who have successfully managed these approaches--both from the site and sponsor sides. Attendees will walk away with details and examples that they can apply to their efforts in clinical trial recruitment.
CEU: 1.00 ACRP
Speakers:
Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus
Karla Polk, Clinical Research Executive
In this session, we will examine barriers impeding effective decision-making and critical thinking in clinical research, including cognitive biases and information overload, and provide tips and scientifically based tools to help study team members navigate difficult decisions. Criteria for fostering a positive decision-making environment, emphasizing transparency and open communication, will also be examined. Attendees will engage in a thorough analysis of the deductive and inductive reasoning processes inherent to clinical research decision-making. By session's end, participants will emerge armed with empirically grounded strategies to navigate complexity, cultivate critical thinking, and drive impactful outcomes in their clinical research endeavors.
CEU: 1.00 ACRP
Speakers:
Ashley Bader, Clinical Research Nurse Manager, Tampa General Hospital
Jennifer Spitzer, Senior Clinical Research Associate, University of South Florida
In a post-pandemic landscape, learning, conducting, and implementing clinical trials significantly changed with the adoption of globally accepted decentralized methods. Variability across educational offerings may not assess learner competency to perform clinical research operational activities. In this panel, clinical investigators, a U.S. Food and Drug Administration representative, and educators will explore varied modalities for training investigators and consider avenues for comprehension in terms of learning on the job, through structured courses, by attending sponsor/contract research organization-conducted trainings, or by completing online modules--none of which may be sufficient in isolation. Fundamentals of online teaching and learning, coupled with adult learning methods and the industry's continued reliance on a "decentralized method of training," are pivotal to assess learner capability. In the absence of documented analysis and evaluation of the effectiveness of micro-credentials, presenters will discuss strengths/weaknesses, gaps, and challenges of the biopharmaceutical industry's reliance on the current modes of training and education of clinical research professionals.
CEU: 1.00 ACRP
Speakers:
Nadina Jose, MD, Assistant Professor, School of Health Profession, Rutgers, The State University of New Jersey
Erika Stevens, MA, FACRP, Director, Research Experience, Rutgers
Watch a Sneak Peek into the Session Content:
Translational research is often driven by independent physician-investigators who want to bring medical innovations to the bedside. These pioneers take on the design, implementation, and compliance needs of their clinical trials, often without any formal training on research methodology. Similarly, lack of formal regulatory training creates challenges for busy investigators balancing their clinical and research responsibilities, and can put institutions at an increased risk of non-compliance, loss of reputation, and liability. Establishing an investigator-initiated research program (IIRP) can address the knowledge gap, foster translational research, and provide a support model that improves the quality of research, enhances reproducibility of results, and ensures compliance while protecting the rights of and maximizing the potential benefits for research participants. The session will focus on the importance of an IIRP regardless of research portfolio size, will deliver scalable steps for success. The example of a bottom-up approach will provide a framework for discussion and opportunity to share lessons learned.
CEU: 1.00 ACRP
Speakers:
Pamela Cooper, Manager, Investigator Initiated Research Program, Hackensack Meridian Health Inc
Elli Gourna Paleoudis, PhD, Director, Investigator Initiated Research Program and Support Services, Hackensack Meridian Health
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Understanding that site management organizations (SMOs) are essentially the bridge between the sponsor/contract research organization (CRO) and sites, we will demonstrate proven quality improvement practices used by SMOs to reduce start-up timelines. Roles discussed involve study activation, regulatory compliance, contracting and budgeting, clinical education, and clinical trial management system oversight. Participants will understand the function of each role and how the delineation of responsibilities improves site compliance, data quality, and sponsor/CRO satisfaction with a site's clinical trials. We will explore best practices using specific examples from real-world experiences, including technology use and templates covering communication, trial management, study and site specifics, etc.
CEU: 1.00 ACRP
Speakers:
Charita Braker, Manager, Clinical Research Education, HCA Healthcare Research Institute
Jessi Klindedinst, Manager, Regulatory Affairs, HCA Healthcare Research Institute
Watch a Sneak Peek into the Session Content:
An estimated 20% to 50% of trial protocols launched at sites will eventually close without a single enrolled participant, wasting considerable resources along the way. While not mandated, feasibility reviews are being utilized by many organizations to minimize the risk of opening studies that ultimately will fail. Stage-gate process, a framework described in industrial organization management, can help identify projects early that are likely not to succeed and stop them before extensive resources are invested, freeing those resources to support other projects more likely to succeed. The feasibility process should include review of a diverse array of resources--financial, human, and physical--as well as the ability to accrue needed participants. This presentation will discuss the stage-gate framework, provide tips on processes that can be used to implement a feasibility process, and offer metrics and data organizations can use to drive the analysis empirically.
CEU: 1.00 ACRP
Speaker:
Wendy Tate, PhD, MS, Product Strategy Senior Director, Advarra
Recent discussions around diversity and inclusion have highlighted the limited participation of Americans in clinical research, with only 10 to 20 million out of 320 million involved. Many solutions, like decentralized clinical trials, focus on making participation easier for those already involved rather than reaching new participants. In my presentation, I will showcase initiatives and technologies aimed at recruiting those not yet participating in clinical studies, stressing that inspiration and education are key to growing the pool of engaged populations.
CEU: 1.00 ACRP
Speaker:
James Morton, PharmD, Adjunct Professor, UC San Diego Extended Studies
Watch a Sneak Peek into the Session Content:
Signature Series Session
Meaningful change can come from the top down and the ground up—but in clinical research, valuable perspectives from seasoned professionals in the field have been silent for too long. This session builds on an NIH survey that was first examined at ACRP 2024 and then expanded upon in a pioneering national survey by ACRP and Continuum Clinical (launching in late November) with the goal of understanding how to improve clinical trials from those who implement and manage trials.
Through the lens of transformation, this survey goes beyond the barriers that are typically captured to explore real-world actionable insights for clinical trial implementation, our current state, where do we want to go from here, and the changes needed to reach an ideal future state.
Come hear wisdom gathered from clinical research professionals just like yourself--and share your voice in this lively discussion! Our speakers will share the survey insights and propose practical, solutions-based approaches to overcome the reported barriers. All ACRP 2025 registrants will receive exclusive access to a pre-read document before the conference to help set the stage for the discussion in New Orleans.
Join us for this engaging session to discover actionable solutions to the issues that hinder successful clinical trials. Your colleagues (and hopefully, you!) have spoken, so don't miss out!
As the leading advocate for clinical research professionals, this effort builds upon ACRP’s mission to promote excellence in clinical research and highlight our members' contributions to the clinical research and drug development sectors. To learn more about the survey and ensure you participate, please contact ACRP.
CEU: 1.00 ACRP
Speakers:
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Krista Ellis, MS, CCRC, Project Manager, University of Utah
Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center
Ashley Moultrie, CCRP, Senior Director, DEI & Community Engagement, Javara
Mary Pautler, MPH, ACRP-CP, Program Director, University of Utah
In this session, we will dive into the history of women leadership and discuss barriers women face in clinical research leadership positions. What is the leadership landscape in clinical research and how can you be an effective leader in it? Let’s create a Blank Space and level the playing field by breaking those barriers. How will we do this? By embracing a journey of change, being fearless, and mastering the strategies necessary for overcoming barriers as a female leader and achieving success.
CEU: 1.00 ACRP
Speaker:
Jessica Fritter, DHSc, MACPR, ACRP-CP, Clinical Assistant Professor of Practice, The Ohio State University
Related Blog Content:
Watch a Sneak Peek into the Session Content:
The session will focus on various types of protocol designs and changes, with an emphasis on adaptive designs. We will review the FDA guidance on “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Taking a deeper dive into unplanned design changes and regulatory considerations, we will engage in one of the oldest thought experiments in Western philosophy, the Ship of Theseus, to address an ambiguity in clinical trial design. Here, we will consider alternative ways protocols are commonly modified, and whether those changes could be considered an entirely new clinical trial, rather than a modification. This session will also provide an educational background in trial design for professionals who haven't had as much exposure to the topic as they wish, and will include a detailed review of sections of ICH E8(R1) and ICH E6(R2), where they relate to trial design.
CEU: 1.00 ACRP
Speaker:
Amanda Egan, Associate Clinical Research Associate, Merck
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.
In this session, an expert panel with members representing a top 10 industry sponsor; a research and policy center; an independent nonprofit organization; and a pharmaceutical business intelligence provider will share actionable insights on expanding the scope of diversity in clinical trials. The panelists will elaborate on the section of the new U.S. Food and Drug Administration (FDA) diversity plan guidance stating that "FDA advises sponsors to seek diversity in clinical trial enrollment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics.
CEU: 1.00 ACRP
Speakers:
Fenwick Eckhardt, Head of Diversity Strategy, Citeline
Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Behtash Bahador (he/him), Director of Health Literacy, Center For Info & Study on Clinical Research Participation (CISCRP)
Watch a Sneak Peek into the Session Content:
The overall focus of this session will be to pose important considerations relevant to the ethics of patient data-sharing and privacy in a rapidly advancing, data-driven research environment. We will seek to raise pertinent questions related to consent, transparency, and the responsible use of patient information via realistic patient case scenarios and audience participation. Scenarios will involve technology utilizing artificial intelligence methodology, data-sharing requests from sponsors, and the tactics involved in operationalizing compliant patient-centered research in an age of Big Data.
CEU: 1.00 ACRP
Speaker:
Gina Remington, RN, MSN, AVP, Strategy and Business Development, HCA Healthcare Research Institute (HRI)
The U.S. Food and Drug Administration's (FDA’s) recent guidance for institutional review boards on informed consent was the first update to the old “information sheets” on the topic in nearly 20 years. The Office for Human Research Protections beat FDA to the punch with new consent form requirements, but does the latest guidance mean there is a new “reasonable person” in the room? In this session, we will break down the new FDA guidance and what it means for accredited Human Research Protection Programs. Some organizations may not need to make any extensive changes, but there are differences between the FDA guidance and the expectations of the Common Rule concerning informed consent that must be considered.
CEU: 1.00 ACRP
Speaker:
James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra
Related Blog Content:
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.
Leveraging electronic tools is essential for maintaining inspection readiness in today's regulatory landscape. Paper-based methods are cumbersome and time-consuming, and they create logistical challenges in record keeping. In contrast, technology offers centralized record keeping, and electronic file storage is now both cost-effective and user-friendly. This shift is underscored by updated guidelines such as ICH E6(R3), which promotes media neutrality, flexibility, innovation, proactive quality, and robust data governance. Additionally, remote regulatory assessments, which were proven effective during the pandemic, enhance efficiency, flexibility, and global reach while reducing travel and disruption. Despite these advancements, recent feedback from regulators indicates a regression in the adoption of these technological tools. It is time for sponsors to embrace risk proportionality, which is supported by regulatory authorities, to maintain inspection readiness.
CEU: 1.00 ACRP
Speaker:
Marc Wartenberger, CQA, CTFL, Senior Director, Security, Corporate QA & Compliance, CRIO
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.
Payment for services in the healthcare industry is handled unlike the payment process for any other business. Learn the different models by which investigators can be compensated; the basics of the Anti-Kickback Statute, the False Claims Act, and the Stark Law; how they govern investigator payment; and the average per-patient investigator compensation by trial type. The speaker will share one hospital’s experience with successfully compensating physicians based on the various types of medical groups and hospital physicians they contract with. In this session, attendees can be prepared to learn about managing investigator payments; creating compensation that is fair, motivational, affordable, practical, legal, and agreeable; and motivating investigators without incentivizing them to perform clinical trials.
CEU: 1.00 ACRP
Speaker:
Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
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.
For more than a decade, multiple sources of regulatory guidance have increased their focus on risk management in clinical studies, paving the way for industry to adopt more risk-based monitoring strategies internationally. With the issuance of ICH E6(R3), an even more focused risk-based approach is expected. While Industry initially struggled to implement risk-based monitoring, moving review into central/remote scenarios as opposed to traditional onsite monitoring, we can now apply lessons learned to various indications and phases of research. We’ve come very far in tailoring systems and approaches to fit the needs of studies while still building in quality by design. Sites are important partners, but have been left out of the conversation about risk-based monitoring. Industry has fallen short in making risk-based monitoring something tangible to sites. Our goal is to bring sites a greater understanding of what sponsors/contract research organizations (CROs) are looking for, how they develop their key risk indicators, and how their ongoing monitoring and mitigation strategies impact their studies.
CEU: 1.00 ACRP
Speaker:
Sara Croteau, Associate Director, Clinical Operations - Quality Management, Innovaderm
Valerie Paolella, Associate Director, Clinical Trial Management, Innovaderm
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 will review the ways in which critical representatives, including patient and caregiver advocates, from across the research landscape can be meaningfully engaged by sponsors and sites to co-develop effective, patient-facing processes or resources. Through the lens of an ongoing community-engaged project, steps and strategies to recruit, engage with, and retain key informants will be presented and discussed. Participants will come away with an appreciation of the opportunities that sustained relationship-building affords a project, as well as tips and techniques for including patients and community members from initiation through dissemination, and beyond. Topics to be covered include health literacy concepts, clear communication strategies, and workgroup facilitation techniques.
CEU: 1.00 ACRP
Speaker:
Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Drop-in for this quick 30-minute "small talk" offering insightful and practical tips from your ACRP peers. Sponsors and CROs will share the guides and templates they are using to develop their Clinical Trial Diversity Plans. Attendees will also walk away with practical tips on how to get started.
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—Investigator Engagement - Saturday, April 26, 2:00 - 2:30 PM
One of the predominate challenges we face in our field is not having enough "hands on deck" to tackle all the work in front of us. This principal issue is accompanied by a litany of subsequent challenges that impact managers, coordinators, sponsors, stakeholders, and most importantly, study patients. We will discuss how to keep a team of research professionals seaworthy across entire studies by diminishing the strain on its members through provision of "floating coordinators" giving temporary coverage for projects and departments on an as-needed basis. We will break the ice on this topic, which we believe will become increasingly relevant, and we'll share our top tips for instituting and managing such programs wherever they are needed in the research enterprise.
CEU: 1.00 ACRP
Speakers:
Michelle Bright, MA, CCRP, Director of Clinical Research Operations, Center for Clinical Research Management, Ohio State University College of Medicine
Diana Burke, MA, CCRC, Lead Clinical Research Coordinator, Center for Clinical Research Management, Ohio State University College of Medicine
Patrick Rowan, MS, CCRP, Senior Clinical Research Coordinator, Center for Clinical Research Management, Ohio State University College of Medicine
Watch a Sneak Peek into the Session Content:
Join us for an engaging, fun-filled session where staff from a large healthcare and research organization will share practical strategies for creating a workshop course series that elevates informed consent training from adequate to superior heights. Identify tactics to address gaps in your informed consent education and to navigate unique informed consent scenarios. Learn how to utilize gameplay applications and simulation activities, and how to share the knowledge of experienced clinical research staff to improve the practices of your novice clinical research workforce. Discover how to enhance your clinical research operations through empowerment of your teams to offer research opportunities to diverse clinical trial participant populations in non-ideal conditions--all while keeping your training exciting and interesting.
CEU: 1.00 ACRP
Speaker:
Cathe Hanson, Education Coordinator - Research, Mayo Clinic
Pam Draayer, CCRP, Education Coordinator - Research, Mayo Clinic
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.
