ACRP is happy to announce forthcoming updates to several courses in the ACRP catalog.
Learn MoreThis package is a replay of 81 on-demand session recordings and presentation slides from the ACRP 2024 Conference, May 3 – 6, Anaheim, California. 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 2024 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 31, 2027.
Innovators in Action: Novel Programs Addressing Workforce and Enrollment Issues
This session highlights industry pioneers with novel approaches to facing workforce challenges and diversity, equity, and inclusion (DEI) issues in clinical trials and overall trial enrollment. Featured are a nonprofit organization focused on community grassroots efforts, an innovator of partnerships with higher education to offer clinical research as an intentional career option, and sponsors who are driving inventive programs to build site capacity with a focus on DEI. Speakers: Lora Black, RN, MPH, Executive Director, Clinical Research – Sanford Research, Sanford Health; Kelly Clark, BScN, MSHS, Head of US Partnerships and Global Site Development, Merck; Michaele Linden Johnson, FACHE, MBA, Senior Director of Clinical Trials and Business Development, Medical Center of the Americas; Sandra Smith, RN, MSN, AOCN, SVP, Clinical Solutions & Strategic Partnering, WCG; Leslie Wolfe, BS, MHA, Director, Clinical Research – Early Talent Development, Merck; Denise Snyder, MS, RD, LDN, Associate Dean for Clinical Research, Duke University School of Medicine (Moderator)
Please join David Burrow from the FDA’s Center for Drug Evaluation and Research (CDER) as he discusses the transformation of clinical research and the advancement of drug development and clinical trial design. David will share perspectives on various clinical trial innovation activities including evolving study designs (e.g., master protocols), operational approaches (e.g., decentralized clinical trials (DCT)), and data sources (e.g., real-world data (RWD)). Hear directly from CDER’s Office of Compliance on balancing the critical interests involved in supporting innovation in clinical research along with the FDA’s role as a global regulatory and enforcement agency focused on protecting public health. 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
It’s not enough to merely set up a clinical research site in an area with an underserved population and leave the chores that will grow patient recruitment and retention at the site unattended to. Hear stories of success concerning how community engagement is required and what the crucial elements are for patient engagement and retention. Speakers: Seneca Harrison, CEO, Quality Clinical Research Inc; Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager, SiteBridge Research Inc; Christopher Romero, MD/PhD, FACP, DABOM, Regional Medical Director, Headlands Research; Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara (Moderator)
While it may not feel like it at times, we are all on this journey toward safer, more efficient, and more effective clinical trials as a team. This session encourages us to listen to the needs of all parties involved in achieving the goals of greater public trust, transparency, and timeliness in research. Join us in a sharing of initiatives and projects demonstrating how we as an industry are securing success on the road of this shared mission. Speakers: Rick Fisher, Senior Vice President, Operations, Velocity Clinical Research; Noelle Gaskill, Head of Clinical Research Collaborations, Mirati Therapeutics; Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc; Erin Stackowitz, US Innovation Lead, Clinical Study Unit, Sanofi; Bernadette Tosti, Head, Digital Trials Customer Solutions, Flatiron; Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare (Moderator)
Best Practices for Accelerating Study Start-Up and Opening with a Bang, Not a Whimper
Lengthy study start-up timelines cost sites and sponsors time and money and may prevent would-be participants from receiving potentially life-saving treatments. This session considers how study start-up sets the stage for trial conduct into the enrollment, maintenance, and close-out phases, so reducing errors and miscommunication during start-up fosters success during the other phases of the trial. Both sponsors and sites alike can take steps to expedite the start-up process using best practices that can enhance the overall conduct of the trial. Speaker: Jessica Propps, Clinical Operations Manager – Regulatory, Merck
Year after year, too many trials are run out of the same few sites, limiting patient access and harming the goals for levels of diversity, equity, and inclusion that will truly benefit the clinical research enterprise and public at large. In this session, Liz will share first-hand insights into how she’s seen sites reimagine their approach to successfully spur greater interest with more sponsors by focusing on building community relationships based on trust and connecting with diverse patient populations. Speaker: Liz Beatty, Co-founder and Chief Strategy Officer, Inato
How can research professionals improve their “elevator pitch,” or that first 60-second message they share with a potential participant in order to have them be in a space where they can truly listen to and engage with information about a study? Drawing from the fields of psychology and marketing, with input from an institutional review board (IRB), this presentation will help the audience identify informed consent elements to include in their roster when the recruitment game gets real. Speakers: Krista Ellis, Project Manager, University of Utah; Brooklyn Henderson, Research Services Consultant, Vanderbilt University Medical Center
With retail pharmacy chains such as Walgreens, Walmart, and Kroger ramping up their clinical trials activities from referring patients to acting as investigative sites, this session will explore attitudes of site personnel, biopharmaceutical executives, and patients concerning the barriers and opportunities to pharmacy involvement on this new horizon for decentralized clinical research. Speakers: Emily Botto, Senior Research Analyst, Tufts Center for the Study of Drug Development; Bree Burks, RN, MSN, Vice President of Strategy, Site Solutions, Veeva Systems; Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc; Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, RWE Clinical Trials, Walgreens; Sara Edwards, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly and Company (Moderator)
Are you wondering if the correct site was selected at Validation? Are you unsure if the selected site will be a good representation of your company? Look no further! “Site Validation/Qualification – Picking the right sites” will offer suggestions to ensure that the correct sites have been chosen. This session will teach you how to select good sites, how to better perform site facility assessments, and understand the overall importance of the validation visit. Speaker: Kristi Pinkston, BS, RN, MABC, Senior Clinical Research Associate, Merck; Carmen Thornton, RN, BSN, Senior Clinical Research Associate, Merck
With a focus on the complexities of research operations, this session will discuss the importance of providing research participation opportunities in underserved communities and adhering to best practices for supporting research teams in a variety of academic, industry, grant-supported, and unfunded settings. Speaker: Polly Mock, RN, ACRP-CP, CHRC, Regional Research Director – South Texas, CHRISTUS Health
Addressing the significant challenge of patient retention in clinical trials, with dropout rates as high as 30%, having the right technology is essential for effective participant recruitment and engagement. In this session, we will explore how ENGAGE!, a comprehensive participant portal and eConsent solution, enhances patient interaction and retention in clinical trials. We’ll discuss the pitfalls of traditional patient recruitment and retention strategies and demonstrate how ENGAGE! offers a more efficient and patient-centric approach for sustainable long-term engagement in clinical studies. Sponsored by RealTime Software Solutions. This session does NOT offer ACRP Contact Hours.
Many clinical trials struggle to recruit enough patients quickly – in fact, a significant portion never enroll a patient. According to global data analysis, 55% of terminated trials cite low accrual rates as the primary reason for termination, while more than 80% of trials worldwide fail to enroll on time. Additionally, the FDA reported that the majority of participants in the US in 2022 were white. Clinical development leaders need help both before trials (planning, site selection, recruitment) and after completion of trials (follow-up and surveillance). To avoid the downfalls associated with recruitment challenges, learn how Inovalon, a leading provider of cloud-based software solutions, and VigiLanz, an Inovalon solution, can help improve trial planning and performance by leveraging Real-World Data (RWD), accelerate recruitment using real-time data, and reduce the time needed to screen patients, increase enrollment, and enhance personnel efficiency. Sponsored by VigiLanz, an Inovalon solution. This session does NOT offer ACRP Contact Hours.
The urgency to revolutionize the process by which sponsors assess a study site’s feasibility for handling a clinical trials has never been more apparent. This session considers how, as trial volumes surge and staffing shortages loom, the frustrations shared by sponsors, contract research organizations (CROs), and sites alike underscore the need for innovative approaches to data collection and site selection that will lead to successful trials. Speakers: Andrea Bastek, PhD, VP of Innovation, Florence Healthcare; Amy Bland, Director of Clinical Research, Baptist Health Institute for Research and Innovation; Victor Chen, Managing Director, Clinical Trials Program, Kaiser Permanente; Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc
Clinical Research Professionals (CRPs) play a key role in the design and implementation of clinical trials, a concept not always recognized by those who fund research or Investigators who carry out the funded research. Leaders at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognized that in recent years, a large proportion of National Institutes of Health (NIH) funded clinical trials have not achieved target enrollment within the allotted time or budget, and some have been terminated early for futility.1 Based on a retrospective review of National Heart, Lung, and Blood Institute (NHLBI) funded trials, only 26% were successfully defined as achieving 100 percent enrollment in the target time allowed. To identify areas of improvement in planning better clinical trials, leaders at NIDDK assembled a committee of Clinical Trial Experts to design a workshop to consider key factors that are critical to a successful trial, including patient and stakeholder engagement, pretrial analysis of the study population and landscape, and ideas for better planning to achieve optimal recruitment. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Krista Ellis, Project Manager, University of Utah; Edwina McNeill-Simaan, Program Director, Vanderbilt University Medical Center; Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara; Mary Paulter, Program Director, University of Utah
When discussing diversity, equity, and inclusion in clinical research, the Deaf community continues to be an underrepresented group. This is due to a massive divide between the Deaf community and the medical world–in terms of barriers to communication, accomodation, trial recruitment, and advocacy, just for starters. In this session, a Deaf clinical research coordinator and their hearing employer will challenge the audience to improve how the research enterprise interacts with the Deaf community, both as study participants and as clinical trial team members. Speakers: Krista Kachnik, BS, Clinical Research Coordinator, The Spine Network; Marcus Stone, PhD, Principal, The Spine Network
Like a first date, the site qualification visit can make or break a relationship. With attention paid to both site and sponsor perspectives, this presentation will range from feasibility to follow-up to ensure all parties are confident that the studies being sought for sites and the sites being sought for studies are “keepers.” Speaker: Lisa Ince, Project Manager, Syneos Health
In a world of increasing data complexity, it is important that clinical research professionals understand foundational data oversight concepts. This session focuses on how successful oversight of the conduct and data quality of a clinical investigation requires multidisciplinary engagement from a range of stakeholders whose roles and responsibilities need to be clearly defined. Speaker: Kathleen Kane, MBA, CCRP, Senior Manager, Clinical Operations, NMDP
Too often, individuals aspiring to become Clinical Research Associates (e.g., Study Coordinators) don’t have the required means to learn about this crucial role. Moreover, new CRAs are often sent into their earliest site monitoring visits with limited practical training or oversight, and with little appreciation for the best practices of veterans in the field. This hands-on workshop is designed to give practical tools and tips on conducting a monitoring visit, fill gaps in basic monitoring knowledge, give an opportunity to practice monitoring scenarios, and provide a judgement-free environment for asking the questions that new CRAs often hesitate to raise with their managers and Study Coordinators struggle to find answers for. Speakers: Demi MacLennan, MS, CCRA, ACRP-PM, Sr. Project Manager, Fortrea; Negar Roofigari, Clinical Trial Manager, Fortrea
This interactive presentation provides an in-depth look at, and tools and resources for, protocol development with the goal of aligning the principles set forth in the U.S. Food and Drug Administration’s draft guidance on diversity, equity, and inclusion (DEI) with the application of methods for decentralized clinical trials (DCTs) in the field. Speakers: Nadina Jose, MD, Assistant Professor, School of Health Professions, Rutgers, The State University of New Jersey
There is an appreciable link between a would-be trial participant’s financial situation and the levels of access and inclusivity in trials. This presentation examines some of the financial challenges to clinical trial participation, solutions and strategies that can be implemented to overcome those barriers, and other considerations for creating a more equitable healthcare system that leaves no patient behind. Speakers: Michelle Chawla, Diversity Program Lead, Merck; Adam Penna, Sr. Clinical Operations Manager, Associate Director, Clinical Operations, Merck
This session is tailored for anyone who wants to learn more about methods for, and the potential impacts of, designing and implementing research through a health equity lens, including tactics for effectively addressing disparities, fostering inclusivity, and enhancing participant engagement through culturally competent strategies. Speakers: Aimee Pehrson, MHA, MPH, CCRC, Researcher, The University of Tennessee and Prometheus Federal Services
With its high percentage of foreign-born citizens, the Canadian landscape presents a golden opportunity for researchers to drive their projects to success, both by developing a diverse workforce, as well as by enhancing diversity in clinical trials participation. This session offers a Canadian perspective on actionable steps that study teams can take to promote diversity and inclusion in their clinical trials projects, as well as the involvement of academia, communities, and the government in empowering the clinical research enterprise to take the lead on meeting diversity, equity, and inclusion goals. Speaker: Munaza Jamil, Faculty Instructor, McMaster University
Attendees in this session will learn from case studies how to assess their organization’s current business strategy, develop a value proposition and competitive advantage, and utilize a structured method leading to a new organizational strategy that is best suited to their situation as a site, contract research organization (CRO), or other stakeholder in the clinical research enterprise. Speaker: Fraser Gibson, Project Manager, Fortrea
There’s no doubt that worker overload drives low morale and high turnover among staff–in clinical research settings no less than anywhere else. This session considers how trial site managers can be fair and equitable with their teams in terms of workload expectations. The development of a workload acuity tool can put measures in place to establish a consistent process leading to better hiring decisions and increased employee satisfaction, efficiency, and productivity. Speakers: Christina Brennan, MD, MBA, Senior Vice President, Clinical Research, Northwell Health; Richard Dima, MD, CCRC, Senior Director, Clinical Research, Northwell Health; Virgenmina Lugaro, Director, Clinical Research, Northwell Health; Kristine McGowan, DNP, Senior Director, Clinical Research, Northwell Health
What if we could bring clinical trial opportunities right to where potential participants get their annual physical, their flu vaccine, and the majority of their care? Hear from an investigator and a leader from an integrated research organization as they discuss the challenges and how they overcame them to build a successful research partnership in a community-based primary care practice. Speakers: Charlotte Grayson-Mathis, MD, Internal Medicine Specialist, First Georgia Physicians Group (Privia Health); Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara
This session will share results from a survey of community health centers (CHCs) nationwide about their experiences, roadblocks, and needs related to supporting clinical studies. A CHC framework and toolkit will be provided so that study sites and sponsors will have the background needed to effectively approach CHCs for clinical trial collaboration. Speakers: Ruma Bhagat, MD, MPH, Principal Portfolio Leader, Health Equity & Population Science, Product Development, Genentech; Pete Fronte, MBA, President & CEO, Altura; Sandy Orzel, Senior Director of Operations & Program Management, Neighborhood Healthcare; Rakesh Patel, MD, MBA, FACHE, CEO, Neighborhood Health
This session is designed to help prepare first-time oncology trial team members to face the ins and outs of complex study designs, laboratory considerations, data gathering and management chores, adverse events reports, tumor response assessment, RECIST vs iRECIST issues, and more. Speaker: Heidi Kirkpatrick, Sr. Clinical Research Associate, Merck
The histories of risk management, banking, library science, and mathematics are all deeply intertwined. This session considers how the tenets of risk management, also known as actuarial science, were first integrated into the clinical research Industry, eventually adopted internationally as part of the ICH E6(R2), and what to expect on the subject in the forthcoming ICH E6(R3) update. Speaker: Crystal Olson, Senior Clinical Project Manager, ProSciento
A Primer on the CMS Criteria for Approving Investigational Device Exemption Studies
When the Centers for Medicare and Medicaid Services (CMS) considers billing issues tied to Investigational Device Exemption (IDE) studies, it’s usually not the facts about such details as the National Clinical Trial number or an institutional review board’s decisions that come into question. More often, CMS is challenging the principal purpose of the study along with its methodology and applicability to Medicare beneficiaries and health outcomes. This session focuses on troubleshooting the “justifications” for the 10 approval criteria that matter most to CMS and learning more about what kinds of IDEs become winners. Speaker: Wendy Schroeder, Principal Strategy Consultant, Clinical. NAMSA
Oversight of Decentralized Components of a Clinical Trial
We will discuss regulatory oversight of clinical trials that use decentralized components. Through this presentation, the audience will hear about regulatory requirements and expectations of the coordination of these trials while using the unique aspects of ‘hybrid’ components. Speaker: Eric Pittman, MBA, Director, Bioresearch Monitoring Division (West), U.S. Food and Drug Administration
With the U.S. Food and Drug Administration making it clear in recent guidance that electronic regulatory records in site-owned systems are definitely subject to CFR 21 Part 11 in the Code of Federal Regulations, this session focuses on how sites need to understand the requirements and develop strategies for compliance. Speaker: Stuart Cotter, VP, Product Strategy, Advarra
This session dives into the U.S. Food and Drug Administration (FDA) policies, guidance, and expectations regarding the collection, creation, and storage of electronic source documentation at study sites. An experienced FDA Investigator will share examples of modern electronic record creation tools, programs, and devices alongside real-world examples of deficiencies observed on inspections and how the deficiencies could be prevented at a clinical site. Speaker: Richard Berning, Foreign Cadre Investigator / Specialist, U.S. Food and Drug Administration
This panel session delivers an interactive discussion on key concepts related to contracting for early feasibility studies, implementing such studies in academic settings, launching enrollment for them after activation, and utilizing them for novel devices. Speakers: Kate Dalton, Director, Cardiology Research, Columbia University; Lynne Goodreau, Administrative Director, Northwestern University; Eileen Mihas, Program Director – Early Feasibility Studies, Medical Device Innovation Consortium
This session will provide valuable insights into European data privacy laws and their effect on EU and UK clinical trials, including an overview of the implications for life sciences organizations globally. With the challenges of jurisdictional specifics and the ever-complex international data-sharing environment, this session will provide guidance on good data protection practices and the processes required to mitigate the risks and build participant trust, therefore leading to improved trial engagement. Speaker: Rob Masson, CEO, The DPO Centre
This session offers a U.S. Food and Drug Administration Investigator’s insights from sponsor inspections that will help you to identify and prevent the problems that may arise for your data and/or application during the collection of tens to hundreds of thousands of documents during a single trial. Speaker: Lakecha Lewis, International Inspection Cadre, U.S. Food and Drug Administration
U.S. Food and Drug Administration (FDA) Investigators have uncovered data integrity issues related to electronic data in clinical trials, resulting in regulatory actions and/or FDA withholding of approval. This presentation will provide insight into electronic data on efficacy and safety and some real-world examples of questionable validity that the FDA has seen recently. Speaker: Craig Garmendia, PhD, MS, Investigator, International Inspection Cadre, U.S. Food and Drug Administration
This session highlights the importance of a successful partnership between research operations and compliance, and will walk through lessons learned from cases of billing and research noncompliance that could only be resolved through effective collaboration and mutual support. Speakers: Kate Cohen, JD, CHC, CHRC, Chief Compliance Officer, Southern Illinois University School of Medicine; Amber Fifer, PharmD, ACRP-CP, Director of Operations, Center for Clinical Research, Southern Illinois University School of Medicine
This panel discussion reviews the ethical, regulatory, and operational challenges of conducting Exemption from Informed Consent (EFIC) trials in cases involving life-saving, emergency treatments when obtaining consent is impossible. Speakers: Kammy Jacobsen, PECARN Program Director, University of Utah, Data Coordinating Center; Ann Johnson, MPH, IRB & HRPP Director, University of Utah, Institutional Review Board; John VanBuren, PhD, Associate Professor, University of Utah
Clinical research regulations, guidances, and advisories that come in an unending stream from the U.S. Food and Drug Administration are a fact of life that no one in the professional can afford to ignore. This session provides a high-level overview of recent and emerging regulatory issues in the conduct of clinical trials and other kinds of research in the United States. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare
Most federally funded, multisite studies already require oversight by a single institutional review board (sIRB), and soon that likely will be true for U.S. Food and Drug Administration-regulated studies. It’s no secret that sIRB review presents challenges for study teams, especially those managing investigator-initiated studies. This session will help you understand your responsibilities related to sIRB review and point you to resources you can take advantage of. Speakers: Polly Goodman, Associate Director of Regulatory Affairs Operations, SMART IRB, Harvard Catalyst | The Harvard Clinical and Translational Science Center; Michael Linke, PhD, Adjunct Professor/Director of Education, University of Cincinnati/SMART IRB
Concerned about capturing subject injury charges? Worried items and services have slipped out the door when Sponsor has agreed to pay? Unsure if all stakeholders have been alerted to a subject injury? Join us and hear about our journey in building a process to train all stakeholders and ensure billing compliance. This presentation is geared to research billing compliance professionals, study coordinators, and site staff involved in operations and administration. Speakers: Kevin Gardner, Jr., Director, Clinical Trials Office, Penn State College of Medicine; Kimberly Perkins, Assistant Director, Clinical Trials Office, Penn State College of Medicine
A Blueprint for Building Actionable Diversity Plans for Clinical Trial Recruitment and Retention
With new regulatory expectations coming to the fore for diversity action plans in Phase III studies, this session will focus on sharing the strategies deployed for actionable plans by on leading company. Speakers: A. Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead, Merck; Yael Symes, PhD, Senior Medical Writer, Merck
Although the U.S. Food and Drug Administration has taken an active role in extending guidance on the conduct of decentralized clinical trials (DCTs), the industry hasn’t seen yet the scale of their adoption hoped for by many because of lack of trust in sites’ abilities to handle such trials on the part of sponsors. This session explores two different site networks and at a high level, with an emphasis on how they and their sponsors worked to comply with regulatory guidance in two different DCT study designs. Speaker: Noelle Gaskill, Head of Clinical Research Collaborations, Mirati Therapeutics
The current regulatory framework for clinical trials was designed for a different era, when the technology of the time mandated centralization of activities that gravitated toward major research institutions, and less emphasis was placed on access to patients who were representative of the population with the diseases being studied. Diversity in research is a high priority, and modernization of clinical trials is key to improving enrollment of participants from underrepresented racial and ethnic populations and increasing access to care. Innovations in technology and trial design have the potential to unlock a new era of clinical research that is more convenient for patients, more reflective of real-world treatment conditions, and more likely to enable participation of a diverse set of individuals. This session will examine how modernized approaches to key regulatory and legislative policies could accelerate the availability of new and breakthrough therapies to patients in need. Speakers: Sara Edwards, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly and Company; Stacy Holdsworth, PharmD, Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company
Creation of an informed consent form can be a time-consuming process, laden with unexpected delays and protracted negotiations between sponsors, institutional review boards (IRBs), and other stakeholders in clinical research. This session will help attendees to better understand the life cycle of an informed consent form as it moves from a global study template to a site-specific document that is used to share critical information with study participants, and to learn strategies for positioning sites with strong rationale for making critical revisions. Speaker: Dawn Pedinelli, Senior Manager, Astellas Pharma
This presentation will provide an overview of how adaptive design trials are often considered more complex than traditional trials, the different types of adaptive trials that are usually accepted by regulators, typical logistical/operational challenges encountered during their implementation, and solutions to overcome such challenges. Speaker: Vatche Bartekian, President, Vantage BioTrials
Even more important than the development of a clinical trial Diversity Plan is the ability to move from intentions to actions in support of diversity, equity, and inclusion in clinical research. This panel discussion will share one company’s approach to developing Diversity Plans, including actionable strategies that are being employed in a cross-functional and collaborative manner. Speakers: A. Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead, Merck; Michelle Chawla, Diversity Program Lead, Merck; Cameron Davis, Associate Director, Clinical Trial Diversity, Merck; LaShanda Gordon, Associate Director, Diversity Program Lead, Merck
With new regulatory guidance, research staff are now asked to stretch beyond their traditional channels to enroll a diverse and inclusive study population. This session will focus on outlining a map, mobilize, and measure strategy to define diversity beyond race and ethnicity and to identify and measure effective channels and strategies to support diversity enrollment goals. Speakers: Linda Davison-Ray, MA, Director, Equity, Diversity, and Inclusion, Duke Clinical Research Institute; M. Patricia McAdams, MS, CCRA, Associate Director, Research Communications and Engagement, Duke Clinical Research Institute
Since the passage of the Orphan Drug Act in 1983, the rare disease patient community has been an active force in the advancement of research and innovation in clinical trials. This session explores the history of clinical research targeting rare diseases, the role rare disease patient advocates have played in advancing innovative clinical research methodologies (including decentralized clinical trials), and what the broader clinical research community can learn from the rare disease community about recruitment and diversity in clinical trials. Speaker: Stephanie Christopher, MA, CCRC, FACRP, Director, Patient Advocacy, Pfizer
As regulatory expectations concerning greater diversity in clinical trials ramp up, a key change in focus for the clinical research enterprise becomes understanding the importance toward the patient experience of incorporating community outreach and engagement into site and sponsor operations. This session offers practical examples of tactics tied to diversity plans, community-based patient engagement, and clinical study recruitment efforts. Speaker: Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager, SiteBridge Research Inc
A Holistic CRA Evaluation Process for Improving Monitoring Visits
This presentation will detail the importance of transparency, positivity, and professionalism framing all aspects of the process for evaluating the performance of clinical research associates (CRAs) during study site monitoring visits. It will review best preparation and communication practices for visit execution that will elevate the evaluation beyond a simple “pass or fail” determination, leading to a better understanding of competent performance, training needs, and the value of trust between evaluators and CRAs. Speaker: Elizabeth Weeks-Rowe, LVN, CCRA, Independent Clinical Research Consultant, Elizabeth Weeks-Rowe Consulting, LLC
This presentation focuses on why assertiveness is a key skill for professionals to master in a clinical trials industry wracked by growing complexity and staffing challenges, and why a lack of it is hurting the quality of studies. Speaker: Agnieszka Finlayson, MSc, MA, Director and Founder, White Wisteria Academy
This session delves into the transformative potential of critical thinking in clinical research, highlighting strategies that can help professionals quickly adapt and build a quality-driven approach as the industry undergoes rapid and continuous changes. Speaker: Matt Baublits, Associate Director, Country Clinical Quality Manager, Merck
No matter your role in clinical research, communication is key, and sometimes difficult conversations are inevitable. We’ll discuss strategies and tools you can apply to negotiating, giving constructive feedback, delivering bad news, and achieving conflict resolution. After this session, you will walk away with a virtual toolkit of skills that will help you to be more comfortable and confident in having difficult conversations. Speaker: Jennifer McLeland, PhD, CCRC, ACRP-PM, RPSGT, Manager, Division of Clinical Research, Washington University School of Medicine
This presentation explores how personality tests can revolutionize the clinical research workplace, including examples of several types of tests that anyone can use at the individual, team, and leadership levels to gain insights for increased collaboration and efficiency. Speakers: Shannon Cox, MCR, BSN, RN, ETRA, Merck; Kaitlyn Rhodes, MCR, ACRP-CP, Clinical Trial Coordinator (CTC), Merck
Ensuring equity and inclusion in experience means pushing beyond simply offering minorities and other underrepresented groups “a seat at the table,” and looking more closely at what happens at that table. This session is for those hoping to drive diversity, equity, and inclusion (DEI) efforts forward for their organization and for our industry. Attendees will come away with a new understanding of the acronym DEI, as well as tools for how to deploy equitable and inclusive practices. Speaker: Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara
This session focuses on the essentials for investing in staff training and development from onboarding through continuing education and retention efforts that will make a difference in your clinical trial team’s productivity and morale. Speaker: Kathleen Ebeling, Senior Study Coordinator, Rochester Clinical Research
Participants in research are too often viewed as passive recipients rather than active members in the research process with individualized needs and personal views. This session focuses on how all members of the clinical trials team can improve participants’ experiences through a better understanding of participant-centric care in research, leading to increased engagement through recruitment and retention, and to more medical advances being available to the public sooner. Speaker: Kimberly Smith, Clinical Research Education Specialist, Tampa General Hospital
All clinical research professionals can benefit from applying the appropriate technologies to their project management and communications needs. This session offers advice on taking control of your work life by learning the right tools and best practices to get better organized, improve your quality and recall, and become a master communicator. Speaker: Suzanne Kincaid, CCRA, ACRP-PM, FACRP , Consultant, Owner, Responsibility Research
A powerful element in study start-up and ongoing study implementation success is the study coordinator. Building a network for coordinators across sites that are conducting the same (or similar) protocols can prove to be the secret ingredient to success. This session will demonstrate the power of peer-to-peer communication, mentorship, and support in a research consortium. Speakers: Teri Crumb, Project Manager, PNRC Consortium; Margaret Kamel, PhD, Director of Research Projects, Emory University, Health Sciences Research Building
Be a communication champion and pave the way for successful clinical trials! Discover the transformative impact of effective communication on trial success. Learn practical strategies to conduct informed consent discussions, provide compassionate updates, and build participant trust. Uncover the secrets to boosting participant retention and satisfaction. PIs, CRCs, and CRAs will unlock clinical trial success through the power of communication. Equip yourself with a communication toolkit with patient education techniques, cultural considerations, and decentralized trial communication solutions. Prepare to excel in a digital era with active listening skills and ethical practices. Elevate your clinical trials with our comprehensive communication approach. Speaker: Naomi Orebiyi, CEO and Founder, UnCharted Access
As a workforce crisis continues to complicate goals for hiring staff with existing clinical research experience, one small contract research organization (CRO) addressed the issue by creating a successful clinical research associate (CRA) training program. This session offers actionable strategies for enhancing clinical research training programs and empowering teams, and lessons learned for fostering a culture of excellence and growth by setting high expectations and providing early guidance for self-sufficiency. Speakers: Kathleen Kane, MBA, CCRP, Senior Manager, Clinical Operations, NMDP; Alisha Mussetter, Manager, Clinical Monitoring Operations, NMDP; Kassandra Nealon, BS, Clinical Research Associate II, NMDP
A thoughtfully crafted clinical research internship experience can create pathways for students to find post-graduation employment and reduce the burden of employers to identify and onboard future professionals. This session focuses on how one institution is targeting undergraduate-level students in the life and health sciences and providing clinical research training during their studies in order to create a new and up-and-coming workforce of clinical research talent. Speakers: Kevin Gardner, Director, Clinical Trials Office, Penn State College of Medicine; Andrea Stevens, Assistant Professor, Penn State University Greater Allegheny
In a time when study coordinator burn-out can have dire add-on effects for entire study teams, this session presents a new role–the study manager–and the tools for making it an effective site-level solution to adjust to a radically changing world of sponsor expectations. Speaker: Jean Kelly, Associate Director of Clinical Operations, Rochester Clinical Research
Patient engagement in clinical research remains a complicated process. Beyond timelines for meeting enrollment targets, effective patient engagement provides opportunities for participation while removing barriers. This session describes leading practices for equipping clinical research professionals with knowledge, comprehension, analysis, and practical application for research. Speakers: Erika Stevens, Faculty Lecturer, MS ACRM Track & Director, Clinical Research Experience, Recherche Transformation Rapide, LLC; Bridget Strong-Benson, PhDc, MBA, CCRP, Associate Executive Director, Clinical Research Education & QI
This session looks at the implementation of the Joint Task Force for Clinical Trial Competency (JTFCTC) Framework for competency-based job positions at two research-intensive academic medical centers (AMCs)–at Duke starting in 2014 and at UAB starting in 2018–and provides an update on related workforce efforts at the institutions. The results will be tied to ongoing national conversations about the clinical research professional workforce shortage. Speakers: Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine; Mark Marchant, MBA, MPH, Director, Clinical Trial Administrative Office, The University of Alabama at Birmingham
This session will focus on building competencies, gaining stakeholder buy-in, and enhancing development in clinical research settings. Attendees will gain hands-on experience they can use to improve their companies and teams. With specific competencies being practiced by the right people, teams will see streamlined processes and eliminated or reduced non-essential tasks, leading to spending optimal time on revenue-generating activities. Furthermore, organization-specific competencies can facilitate better communication and increase the effectiveness of employee development. Speakers: Mallory Frazier, MS, Manager of Learning and Development, Javara Inc.; Lauren Fregonese, Senior Director of Learning and Development, Javara Research; Michaela Mahin, Talent Management Specialist, Javara Inc.
This session focuses on one organization’s experience with developing its clinical project management workforce through interdepartmental cooperation and the incorporation of the Joint Task Force for Clinical Trial Competency’s framework for job roles. Examples will be shared of the tools and diverse communication methods used to encourage better engagement and synthesis of information leading to a highly trained and agile clinical research team. Speakers: Kim Bloom, MPA, CCRC, Clinical Research Project Manager, University of Utah, Department of Pediatrics, Division of Critical Care, Data Coordinating Center; Heather Gramse, BS, CCRP, Program Director, University of Utah, Department of Pediatrics, Division of Critical Care, Data Coordinating Center; Marie Kay, BA, PMP, LSSGB, CCRC, Program Director, University of Utah, Department of Pediatrics, Division of Critical Care, Data Coordinating Center
This session will evaluate clinical trial operations at the site level and provide novel approaches for improving operations while providing effective oversight. These approaches will include redefining the roles of research team members to help retain quality professionals on board, from coordinators to principal investigators and everyone in between. Speakers: Lacey Andrews, MS, CCRC, CCRA, Lead Clinical Research Coordinator, Marshall University’s Joan C. Edwards School of Medicine, Department of Family and Community Health; Todd Davies, PhD, Associate Director of Research, Joan C. Edwards School of Medicine
Too many clinical research professionals recall being “thrown into” their first role and the sink-or-swim sense of pressure that resulted. Thankfully, clinical research training has evolved to better prepare individuals for real-world research situations. This session looks at how today’s in-person and virtual tools for simulation-based learning create a safe but realistic environment for individuals entering the field to master research processes, apply critical thinking skills to problem-solve challenges, practice using clinical trial technologies, and gain confidence. Speaker: Sharleen Traynor, PhD, MPH, Director, Clinical Trials Research Associate Program, Durham Technical Community College
Explore how one institution implemented an informed consent training program through both didactic training and simulated consenting scenarios. Upon completion of this activity, learners will be able to implement similar programs at their home institutions. Speaker: Kevin Gardner, Jr., Director, Clinical Trials Office, Penn State College of Medicine
Ongoing staff turnover challenges in the midst of burnout trends, talent poaching, career changes, and other trends can leave hiring and training officers feeling as if they are in the middle of a war to attract and retain talent. This session looks at staff retention strategies, best hiring practices, out-of-the-box recruiting strategies, and how to cultivate a culture of communication in order to build a functional and effective team. Speaker: Lauren Stockwell, Director of Outreach & Engagement, Clinical Research Fastrack
Clinical research staffing demands ebb and flow during the protocol and subject management lifecycle. In this session, Jaylene Weigel (Senior Director of Clinical Research Management and Support, Children’s Mercy Hospital) and Emily Traw (Consulting Manager, Huron) will discuss their experience validating the need for a centralized clinical research professionals support model, review essential elements of the model design process, provide an overview of benefits and drawbacks of the model and rationale for use at Children’s Mercy, and lessons learned during implementation. This session is appropriate for all levels of attendees, but particularly those in leadership roles. Attendees will walk away with an understanding of the processes and tools used as this site identified and designed their staffing model. Speakers: Emily Traw, Consulting Manager, Huron Consulting Group; Jaylene Weigel, Senior Director of Clinical Research Support and Management, Clinical Trials Office, Children’s Mercy Hospital
For sites that have embraced decentralized clinical trials (DCTs), the road has often been bumpy, but even those who haven’t cannot avoid them forever. This session provides real-world strategies on how sites can implement the technologies necessary for providing increased flexibility in collecting, monitoring, and reporting clinical trial data when conducting DCTs that will satisfy regulatory expectations. Speakers: Heather Bowman, BSN, RN, ACRP-CP, Regional Site Manager, The Spine Network; Marcus Stone, PhD, Principal, The Spine Network
We all know how to run research, so why do the processes change so drastically between countries and regions? Nowhere is this more prevalent than when using technology; the processes, the procedures, and the regulatory challenges often feel like the wild west, so why is this? Is it an agency issue, or is it a wider industry issue? Throughout this session, you will acquire a more comprehensive understanding of the ongoing debate between “Regulation versus Implementation.” Is it a matter of regulations or a cultural issue specific to a region or country? Being able to grasp these subtle differences is crucial to putting research technology into context as your studies progress and new locations are added. Speaker: Sara Saunders, Manager, Regulatory Affairs, Florence Healthcare
Buzzworthy as they may be, decentralized clinical trials (DCTs) do not hold all the answers for modernizing clinical research. This session focuses on common challenges and pitfalls encountered when implementing new research models and solutions, strategies for maintaining innovation and resilience amidst disruptions and setbacks, and lessons learned for fostering advancement in research projects to come. Speakers: Mo Ali, Chief Domain Expert, Decentralized Care, Medable, Inc.; Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare; Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, RWE Clinical Trials, Walgreens
ChatGPT, an artificial intelligence (AI) tool, has the potential to revolutionize the creation of informed consent forms and related documents for clinical trials. This session focuses on developing concise, participant-centered, and compliant consent forms, and on addressing limitations in sponsor or institutional customization, compliance, and data privacy regulations. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Ann Johnson, PhD, MPH, IRB & HRPP Director, University of Utah, Institutional Review Board; John VanBuren, PhD, Associate Professor, University of Utah
As artificial intelligence (AI) becomes an inescapable fact of daily life, in this interactive session, attendees will obtain a basic understanding of how AI has been used in clinical research to date and what it may make possible in the future. Speakers: Jeff Sidell, Chief Technology Officer, Advarra; Wendy Tate, PhD, Director of Advanced Analytics and Research Optimization, Advarra
While eRegulatory (eInvestigator Site File) systems favored by study sponsors offer many advantages to sites, their adoption and use may place burdens on site personnel that can be alleviated with careful planning and collaboration between partners. Speakers in this session will share specific use cases where the use of eRegulatory has made a positive impact on clinical trials, as well as overall metrics on site adoption, user feedback from site and sponsor roles, and lessons learned and future opportunities for both study coordinators and monitors. Speakers: Dan Knight, Associate Director of Clinical Research, Merck; Kayla Perry, Clinical Research Associate, Merck
Addressing the significant challenge of patient retention in clinical trials, with dropout rates as high as 30%, having the right technology is essential for effective participant recruitment and engagement. In this session, we will explore how ENGAGE!, a comprehensive participant portal and eConsent solution, enhances patient interaction and retention in clinical trials. We’ll discuss the pitfalls of traditional patient recruitment and retention strategies and demonstrate how ENGAGE! offers a more efficient and patient-centric approach for sustainable long-term engagement in clinical studies. Sponsored by RealTime Software Solutions. This session does NOT offer ACRP Contact Hours.
Many clinical trials struggle to recruit enough patients quickly – in fact, a significant portion never enroll a patient. According to global data analysis, 55% of terminated trials cite low accrual rates as the primary reason for termination, while more than 80% of trials worldwide fail to enroll on time. Additionally, the FDA reported that the majority of participants in the US in 2022 were white. Clinical development leaders need help both before trials (planning, site selection, recruitment) and after completion of trials (follow-up and surveillance). To avoid the downfalls associated with recruitment challenges, learn how Inovalon, a leading provider of cloud-based software solutions, and VigiLanz, an Inovalon solution, can help improve trial planning and performance by leveraging Real-World Data (RWD), accelerate recruitment using real-time data, and reduce the time needed to screen patients, increase enrollment, and enhance personnel efficiency. Sponsored by VigiLanz, an Inovalon solution. This session does NOT offer ACRP Contact Hours.
Dive into the heart of AI innovation with Walter Storm, a seasoned data scientist, as he unfolds the mysteries of generative AI models and their groundbreaking journey towards multimodal intelligence. This exploration isn’t just about the algorithms that power today’s AI but a visionary look into how these technologies are reshaping clinical research. From the fundamental principles of language models to the thrilling prospects of AI-driven healthcare advancements, Walter will guide you through the building blocks of AI technology, demystifying complex concepts and showcasing real-world applications. Whether you’re an AI enthusiast or a clinical research professional, prepare to be inspired by the future of AI in enhancing human performance and healthcare solutions. Speaker: Walter Storm, Co-founder and CEO, Aspen Insights. Sponsored by Aspen Insights. This session does NOT offer ACRP Contact Hours.
Feeling overwhelmed by new tech promises? You’re not alone. Research sites are drowning in a sea of options and shiny promises from vendors, but remain skeptical about the actual time and cost savings experienced by real sites. In this panel, research pros share how they transformed their workplace with guidance from vendors they trust. Hear firsthand how the right tools and processes enabled them to: save time and reduce expenses, expand research without hiring more people, keep good employees and improve the quality of their work, and accurately monitor how resources are used across studies. Forget sales pitches — dive into authentic stories straight from the source. You’ll walk away with actionable tips and a renewed belief that technology can shape a brighter future for research sites. Speakers: Alisha Garibaldi, MSc, CEO, Skylight Health Research; Jennifer Scott, RN, BSN, Regulatory Division Manager, Vanderbilt Coordinating Center; Rebecca Hudson, CHC, CHRC, Manager of Regulatory Affairs, Sansum Diabetes Research Institute; Bree Burks, RN, MSN, Vice President of Strategy, Site Solutions, Veeva Systems. Sponsored by Veeva Systems. This session does NOT offer ACRP Contact Hours.