This package is a replay of 26 on-demand session recordings and presentation slides from the Study & Site Management Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Learn practical, proven ways to maximize study and site performance.
Member: $99 | Nonmember: $149
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.
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
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)
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
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)
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