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.

CEU: 1.00 ACRP

Speaker:

• Agnieszka Finlayson, MSc, MA, Director and Founder, White Wisteria Academy

Related Blog Content:

• Never Fear, Assertiveness is an Indispensable Soft Skill for Clinical Researchers

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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.

CEU: 1.00 ACRP

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

Related Blog Content:

• Lessons Learned from Implementing Competency-Based Job Classifications at Two AMCs

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Join us for Meet & Greet with Keynote Speaker, Dr. Romie Mushtaq, immediately following the live session. This is a unique opportunity to engage with our keynote speaker, get your questions answered, and dive deeper into the topics discussed during the live session.

Related Session:

• Power of Pause: Mindfulness to Transform Individuals, Teams & Cultures

techXpo Session
Presented by Aspen Insights

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

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.

CEU: 1.00 ACRP

Speaker:

Dawn Pedinelli, Senior Manager, Astellas Pharma

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Keynote Session
Signature Series Session

Change is a four-letter word that fosters fear. How will you lead your life without the worry and stress of change? Mindfulness teaches us that we are not just coping with "a new normal" but creating a new way of being. When we operate in the workplace from a subconscious realm of fear, stress-related symptoms of anxiety, panic, inability to focus, and insomnia predominate. The Power of Pause transforms us into mindful leaders who quickly face fears, rise above the panic, and find a path to calm consciousness. During this interactive mindfulness session, take a moment to pause, connect back to calm, and get refocused. We will practice scientifically proven breath and meditation techniques to use in the workplace and personally for improved focus, mood, and sleep.

CEU: 1.00 ACRP

Speaker:

Romie Mushtaq, MD, Chief Wellness Officer, Great Wolf Resorts

Related Blog Content:

Getting to the Root of the ‘Busy Brain’ Challenge Can Lead to Better Research Conduct

Keynote Event:

Keynote Speaker Meet & Greet: May 4, 3:00 - 4:00 PM

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Join us in Platinum 7 - 8 for lunch while connecting with 100+ leading-edge organizations and suppliers helping you get better results in clinical research.

Drop-in for this quick 30-minute "small talk" offering insightful and practical tips from your ACRP peers. Sponsors and CROs will share the guides and templates they are using to develop their Clinical Trial Diversity Plans. Attendees will also walk away with practical tips on how to get started.

Feel free to bring your coffee or meal with you. This will be a casual spot where you can learn from—and connect with—your colleagues.

This session does NOT offer ACRP Contact Hours.

Additional Small Talk Sessions:

• Budgeting Tips for the Future: Saturday, May 4, 9:30 - 10:00 AM

• Budgeting Tips for the Future: Sunday, May 5, 9:30 - 10:00 AM

• Crafting Your Clinical Trial Diversity Plans: Sunday, May 5, 12:30 – 1:00 PM

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. 

CEU: 1.00 ACRP

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

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.

CEU: 1.00 ACRP

Speaker:

Polly Mock, RN, ACRP-CP, CHRC, Regional Research Director - South Texas, CHRISTUS Health

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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

CEU: 1.00 ACRP

Speaker:

Wendy Schroeder, Principal Strategy Consultant, Clinical. NAMSA

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.

CEU: 1.00 ACRP

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

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techXpo Session
Presented by VigiLanz, an Inovalon solution

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.

Speakers:

• Jen Lamppa, AVP of Clinical Analytics, Inovalon

• Jocasta Olp, PharmD, MBA, VP of Business Operations and Strategy, VigiLanz, an Inovalon solution

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.

CEU: 1.00 ACRP

Speakers:

• Kevin Gardner, Director, Clinical Trials Office, Penn State College of Medicine

• Andrea Stevens, Assistant Professor, Penn State University Greater Allegheny

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.

CEU: 1.00 ACRP

Speaker:

Noelle Gaskill, Head of Clinical Research Collaborations, Mirati Therapeutics

Related Blog Content:

A Success Story of a Site-Centric Approach to Hybrid DCTs

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techXpo Session
Presented by RealTime Software Solutions

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.

Speaker:

Alex Jenkins, Participant Engagement Product Manager, Realtime Software Solutions

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.

CEU: 1.00 ACRP

Speaker:

Jessica Propps, Clinical Operations Manager - Regulatory, Merck

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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.

CEU: 1.00 ACRP

Speaker:

Eric Pittman, MBA, Director, Bioresearch Monitoring Division (West), U.S. Food and Drug Administration

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.

CEU: 1.00 ACRP

Speakers:

• A. Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead, Merck

• Yael Symes, PhD, Senior Medical Writer, Merck

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Kathleen Ebeling, Senior Study Coordinator, Rochester Clinical Research

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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.

CEU: 1.00 ACRP

Speakers:

Krista Ellis, Project Manager, University of Utah

Brooklyn Henderson, Research Services Consultant, Vanderbilt University Medical Center

Watch Sneak Peeks into the Session Content:

Drop-in for this quick 30-minute "small talk" offering insightful and practical tips from your ACRP peers. Clinical research sites will share their budgeting tips, including two new budget line items they've recently added and the line items they struggle to get approved by the Sponsor/CRO.

Feel free to bring your coffee or meal with you. This will be a casual spot where you can learn from—and connect with—your colleagues.

This session does NOT offer ACRP Contact Hours.

Additional Small Talk Sessions:

• Crafting Your Clinical Trial Diversity Plans: Saturday, May 4, 12:30 – 1:00 PM

• Budgeting Tips for the Future: Sunday: May 5, 9:30 - 10:00 AM

• Crafting Your Clinical Trial Diversity Plans: Sunday, May 5, 12:30 – 1:00 PM

Join us in the Expo Hall from 9:00 AM - 2:00 PM and 4:00 - 6:00 PM for networking with exhibitors and your clinical research colleagues.

Breakfast will be served in the Expo Hall from 9:00 - 10:00 AM, and the Networking Reception will be held from 5:00 - 6:00 PM.

Join us at the Expo for breakfast while connecting with 100+ leading-edge organizations and suppliers helping you get better results in clinical research.

Signature Series Session

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.

CEU: 1.00 ACRP

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)

Related Blog Content:

• Innovators in Action: Novel Programs Addressing Workforce and Enrollment Issues

Watch a Sneak Peek into the Session Content:

Network with your community and enjoy morning coffee in the Platinum Ballroom before and during our Signature Series session, Innovators in Action: Novel Programs Addressing Workforce and Enrollment Issues.

When you arrive in Anaheim, make your way to the registration area to receive your conference badge and essential materials, ensuring you're fully equipped for four days of engaging education sessions and valuable networking experiences.