This package is a replay of 74 on-demand session recordings and presentation slides from the ACRP 2025 Conference, April 24 – 27, New Orleans, Louisiana. It includes content from the six educational tracks, the Signature Series sessions, and techXpo sessions, presented by a variety of clinical research service providers.
Note: These ACRP 2025 sessions will appear on your course dashboard individually as the titles seen below.
Member: $499 | Nonmember: $699
Participants can earn up to 24 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 23, 2028.
Join ACRP’s Executive Director and board members in a town hall setting for an open mic event that will geaux beyond a typical conference kick-off! We’ll explore the importance of community, connection, and maintaining confidence in uncertain times and invite you to bring your experience and best ideas to support your colleagues during demanding times. Let’s convene to talk strategies for coping and use the power of networking to support our community of clinical research professionals. Speakers: Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President, Clinical Research, Northwell Health; Catherine Gregor, MBA, CCRC, Chief Clinical Trial Officer, Florence Healthcare; R’Kes Starling, RPh, MBA, Chief Executive Officer/President, Reveles Clinical Services; Susan P. Landis, Executive Director, Association of Clinical Research Professionals (Moderator)
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. Speakers: Katherine Mary Marangio, Learning Program Consultant, Parexel Academy; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC; Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University (Moderator)
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 in December 2024, with the goal of understanding how to improve clinical trials from those who implement and manage trials. 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. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Paul Ivsin, Executive Vice President, Trial Engagement Service, Continuum Clinical; Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center; Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc; Pamela Tenaerts, MD, Chief Scientific Officer, Medable; Jennifer Sheller, Senior Vice President, Head of Global Clinical Trial Operations, Merck (Moderator)
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. Speakers: Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus; Lisa Moneymaker, Head of Strategic Customer Engagement, Medidata Solutions; David Vulcano, LCSW, MBA, CIP, RAC, FACRP, VP Clinical Research Compliance & Integrity, HCA Healthcar; Pamela Tenaerts, MD, Chief Scientific Officer, Medable (Moderator)
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. Speakers: Charita Braker, Manager, Clinical Research Education, HCA Healthcare Research Institute; Jessi Klindedinst, Manager, Regulatory Affairs, HCA Healthcare Research Institute
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. Speakers: Elisa Cascade, MBA, Chief Product Officer , Advarra; Vanessa Hill, Director, Research Compliance, Advarra Consulting – Institutional Research; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
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. Speaker: Rochelle Williams-Belizaire
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. Speaker: Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
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. Speaker: Ashley Moultrie, CCRP, Associate Director, Clinical Trial Diversity, Syneos Health
Whether you’re new to negotiating budgets or have been doing it for years, budgets can be daunting—each budget is different, challenging, and full of ever-changing details. What shouldn’t change is how you handle budgets from one time to the next, so it’s time to standardize your budget review process. During this session, you’ll learn how to determine costs at your site and then maintain, track, and update those costs while implementing a plan to use what you’ve developed. We’ll also discuss how to review a protocol to uncover hidden costs that can then be factored into your budgets. Speaker: Matt Lowery, ACRP-CP, CCRC, CEO / Principal Consultant, The Pathways Grp, LLC
Patient recruitment remains a significant challenge in our industry, often exacerbated by outdated U.S. Food and Drug Administration 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. Speakers: Meghan Joseph, Site Engagement, Patient Recruitment & Retention, Moderna; Matthew Maxwell, Chief Growth Officer, Centricity Research; Jason Rush, BS, CIP, Senior Director, Regulatory, Advarra; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
With an educational sponsorship from Roche/Genentech, a team of collaborators from Genentech, the Association of Cancer Care Centers (ACCC), and ACRP united to study the impact of clinical research training at ACCC community cancer programs. Join the program leaders as they discuss the results of the impact of providing foundational and therapeutic area-specific clinical research training (oncology) at select ACCC community cancer programs to create a blueprint for training research-naïve oncology staff in the community setting. Included in the discussion are the results of a participant survey that report that learners believed the program improved their knowledge and confidence. Speakers: Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science (HE&PS), Product Development, Genentech, Inc.; Kimberly Demirhan, MBA, BSN, RN, Assistant Director, Education Programs, ACCC; Mona Gilliam MSN, APRN-BC, CNS, Director Medical Strategy: Congress, Alliances, Societies, Genentech; Kemi Oladipupo, Touro Cancer Center; Marian Valia, Head of Learning & Development, ACRP This session does NOT offer ACRP Contact Hours.
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. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; 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
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? 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
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. Speakers: 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); Fenwick Eckhardt, Head of Diversity Strategy, Citeline; Meghan McKenzie, MA, Director of Health Equity and Clinical Research, Genentech’s Chief Diversity Office
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. Speaker: Wendy Tate, PhD, MS, Product Strategy Senior Director, Advarra
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. Speakers: Amine Sehboub, BSc, PgD, Pharm, Clinical Research Associate, Syneos Health; Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
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. 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
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. Speakers: Krista Kachnik, BS, Clinical Research Coordinator, The Spine Network; Marcus Stone, PhD, ACRP-CP, Principal, The Spine Network
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. 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
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. Speaker: Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
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. Speakers: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare; Sophia McLeod, Advocacy Advisor, Association of Clinical Research Organizations (ACRO)
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. 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
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. Speakers: Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus AI; Karla Polk, Clinical Research Executive
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. 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
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. Speakers: Tamika Harris, Clinical Operations Manager – Regulatory, Merck; Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, Merck
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. Speaker: Mark Metzner, Senior Manager, Patient Recruiting & Feasibility, CTI Clinical Trial Services, Inc.
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. 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
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. Speakers: Sara Croteau, Associate Director, Clinical Operations – Quality Management, Innovaderm; Valerie Paolella, Associate Director, Clinical Trial Management, Innovaderm
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. Speakers: MaryAnn Bowman, Founder / CEO, ClinGRO Solutions; Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
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. Speakers: Samantha Herbst, Manager, Huron Consulting Group; Shreya Singh, Senior Associate, Huron Consulting Group
This session will provide a high-level overview of the emerging regulatory environment governing clinical research. With a new administration in the White House and 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, this is a session providing value for stakeholders across the entire clinical research enterprise. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, FACRP, VP Clinical Research Compliance & Integrity, HCA Healthcare
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. Speakers: Betty Donoval, Director, Research & Regulatory Affairs, Cook County Health; Pamela Gonzalez, Manager Research Consultant, Huron LLC
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. Speakers: Lisa Colton, Clinical Regulatory Lead, BSI; Regina Fulkerson, PhD, Director, Clinical Evidence Planning & Evaluations, Varian Medical Systems; Jamie Mangold, PhD, Clinical Evidence Planning & Evaluations Manager, Varian Medical Systems; Eric Sugalski, Founder & CTO, Archimedic
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. Speaker: Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
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. Speaker: Steffi Leung Newell, MS, RN, OCN, CCRC, Clinical Research Nurse, Rush Medical Center
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. Speaker: Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
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. Speaker: Lauren Blizzard, MCR, Emerging Talent Rotational Associate, Merck
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. Speaker: Rob Masson, CEO, The DPO Centre
Join a seasoned U.S. Food and Drug Administration (FDA) Investigator for an overview of how to “stress test” your electronic source (eSource) documents to ensure that they are compliant with FDA regulations and current guidance. This session offers a brief overview of regulatory requirements governing the creation, maintenance, and storage of electronic data at clinical sites and reviews some examples of shortcomings observed in FDA inspections that resulted in FDA Form 483s (Notice of Inspectional Observations) and even Warning Letters. We will also review different types and sources of eSource documentation, including digital health technology, registries used to source real-world data, and electronic medical records, and review common pitfalls associated with them. After the presentation, there will be a live Q&A opportunity. Speaker: Barbara Wright, JD, Senior Advisor, Office of Bioresearch Monitoring Inspectorate, Office of Inspections & Investigations, U.S. Food and Drug Administration
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. Speaker: James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra
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. Speaker: Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
Leslie Sam and Beth Bieze will lead this interactive Q&A session where you’ll have the opportunity to ask questions in an informal setting and benefit from knowledge-sharing with your ACRP peers. This session will continue the conversation from ACRP’s live webinar, Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3). The webinar content was designed to help clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance. Speakers: Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.; Katherine Mary Marangio, Learning Program Consultant, Parexel Academy; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
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. Speakers: Marc Wartenberger, CQA, CTFL, Senior Director, Security, Corporate QA & Compliance, CRIO
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. Speaker: Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems
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. Speaker: Robert Romanchuk, CIP, Chairperson, Univo IRB
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. Speaker: Sara Saunders, MHA, CCRP, Sr. Manager, Regulatory Affairs, Florence Healthcare
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. Speaker: Mark Brandon-Grove, Head of Clinical Research Performance & Quality, The Royal Marsden NHS Foundation Trust
It seems as if everyone has their own way of designing case report forms (CRFs). For study coordinators, this 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. There’s always a bit of copying and pasting happening, too, in the 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 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 useful. During this talk, a research coordinator-turned-clinical research associate will also provide insight into how they contribute to the review process to ensure study flow at the site is taken into consideration. Speakers: Anna Rillo, BSN, RN, Study Director, Bright Research; Robin Solinsky, BS, VP, Technology & Innovation, Bright Research
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. Speaker: Shanna Ford, MHA, Research Office Senior Associate, Huron Consulting Group
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. Speaker: Elke Ydens, Associate Director of Business Solutions, Anju Software
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. Speaker: Amanda Egan, Associate Clinical Research Associate, Merck
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). Speaker: Kimberly Bullock, PhD, CCRP, Director, Protocol Development Team and Associate Professor of Research, University of Virginia
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. Speaker: Patricia Smith, Senior Clinical Data Manager, NAMSA
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. Speaker: Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
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. Speaker: Megan Lamberti, Vice President of Clinical and Regulatory Affairs, Nilo Medical Consulting Group
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. Speakers: Ashley Bader, Clinical Research Nurse Manager, Tampa General Hospital; Alecia Sorrells, MS, BSN, RN, Clinical Research Nurse, Tampa General Hospital
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. 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
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. Speaker: Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
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. 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
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. Speaker: Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University
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. Speaker: Thobe Mthethwa-Pitt, Senior TrialHub Clinical Trials Education Manager, Alfred Health
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. Speakers: Micki Le, Director or CRCs and PMs, SiteBridge Research; Lauren Stockwell, Content & Engagement Manager, Society for Clinical Research Sites
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. 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
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. Speaker: Tia Warrick, DHSc, MPH, CCRA, ACRP-PM, Chief Executive Officer, Lesous Consulting LLC
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. Speakers: Nadina Jose, MD, Assistant Professor, School of Health Profession, Rutgers, The State University of New Jersey; Anita Kablinger, MD, CPI, FAAP, FAPA, FACRP, FASCP, Professor, Academic Vice Chair and Director of Clinical Research, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, Virginia Tech Faculty of Health Sciences; Erika Stevens, MA, FACRP, Director, Research Experience, Rutgers
Research team retention and engagement heavily impacts enrollment and program performance. Join Michelle Rowe from HCA Healthcare Research Institute, as she leads a discussion on talent retention, onboarding, and colleague development. During the panel discussion attendees will hear from HCA Healthcare leaders from Site Operations, Quality & Compliance, Strategic Projects, and Human Resources on the important challenges facing programs today and practical and effective pathways forward. Leave the discussion with knowledge on approaches to onboarding across over 43 sites of care with a core belief that HCA Healthcare’s greatest strength is its talent. Discover practical strategies to standardize talent retention by making actionable ownership of colleague development an intrinsic part of the culture of your program. Speakers: Andrea Berkovsky, Director of HR, HCA Healthcare Research Institute; Lauren Horton, PhD, Director of Research, North Texas Division, HCA Healthcare Research Institute; Sybil Hyatt, MBA, RN, AVP Site Operations, HCA Healthcare Research Institute; Michelle Rowe, RN, VP, Research Institute, HCA Healthcare Research Institute; Robbin Seago, AVP Research Ethics & Compliance, HCA Healthcare Research Institute This session does NOT offer ACRP Contact Hours.
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. 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
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. Speakers: Cathe Hanson, Education Coordinator – Research, Mayo Clinic; Pam Draayer, CCRP, Education Coordinator – Research, Mayo Clinic
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. Speakers: Hannah Culpepper, CCRC, Clinical Research Coordinator, Medical University of South Carolina; Stephanie Schorr, CCRC, Clinical Research Coordinator, Medical University of South Carolina
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. Speaker: James Morton, PharmD, Adjunct Professor, UC San Diego Extended Studies
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. Speakers: 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
Managing clinical trials can feel overwhelming when systems are disconnected and data are scattered. In this techXpo, we’ll explore how a site operations management system (SOMS) transforms chaos into streamlined efficiency. Learn how an integrated platform strengthens compliance, improves workflow automation, and boosts overall site performance—empowering research teams to focus on what truly matters: advancing clinical trials. Speakers: Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions; Nathan Levens, Vice President of Product Strategy, Head of Quality Management, RealTime eClinical Solutions. Sponsored by RealTime eClinical Solutions. This session does NOT offer ACRP Contact Hours.
For too long, clinical trial site operators have had to rely on outmoded, time-consuming processes to pre-screen and enroll participants—only to see a significant number of them screen-fail down the line. Relying on participant questionnaires, interview notes, and fragmented medical records is unacceptable in today’s high-tech, data-driven world. Join this session to learn about Irix®—a groundbreaking software as a service (SaaS) tool that quickly and easily includes or excludes participants at every stage of your unique clinical trial. Speaker: Alyssa Vincze, Principal and Director, R&D, Milliman IntelliScript. Sponsored by Milliman IntelliScript. This session does NOT offer ACRP Contact Hours.