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.

CEU: 1.00 ACRP

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

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

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

Related Blog Content:

• Prioritizing a Positive Patient Experience

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.

In an unprecedented move, they reached out to ACRP to be represented among their clinical trial experts.  Early work with the meeting organizer revealed that they wanted to hear from research coordinators, but did not realize there were many other research professionals that play pivotal roles in the design and implementation or trials.  A panel of CRPs was assembled and given an hour on the agenda for a panel discussion. The panel was asked, "if you thought anyone was really listening, what would you tell them?"  The goal was to give voice to the previously unheard. 

ACRP fielded a brief survey to its clinical research professional community of nearly 90,000 from June 5 to June 30 to capture perspectives from CRPs on challenges related to implementing clinical trials in advance of a July 2023 webinar hosted by NIDDK.  One hundred CRPs completed the survey.  This survey data was presented to the workshop audience of NIH funders and Physician Investigators.  Come and see the survey results and hear the outcome of this partnership.  Critical resources were identified by our CRP audience that included investigator cooperation and support, sponsor engagement, as well as training, oversight, recognition, salary, and compensation to name just a few.  Among the critical resources identified by our boots-on-the-ground CRP colleagues, this initiative yielded 14 valuable resources that are crucial for optimizing and contributing to clinical trial success. Participants will walk away with a wealth of excellent strategies to bolster future clinical trials.

CEU: 1.00 ACRP

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

Watch a Sneak Peek into the Session Content:

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."

CEU: 1.00 ACRP

Speaker:

Lisa Ince, Project Manager, Syneos Health

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Richard Berning, Foreign Cadre Investigator / Specialist, U.S. Food and Drug Administration

Watch a Sneak Peek into the Session Content:

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 crossfunctional and collaborative manner.

CEU: 1.00 ACRP

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

Watch a Sneak Peek into the Session Content:

Signature Series Session

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.

CEU: 1.00 ACRP

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)

Related Blog Content:

• Planting a Seed is Not Enough: Nurturing Community Engagement to Grow Patient Recruitment and Retention 

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

• 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

techXpo Session
Presented by VEEVA

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

• 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

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.

CEU: 1.00 ACRP

Speaker:

Stephanie Christopher, MA, CCRC, FACRP, Director, Patient Advocacy, Pfizer

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara

Related Blog Content:

How Equity and Inclusion Drive True Diversity in Clinical Research

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Rob Masson, CEO, The DPO Centre

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speakers:

• Shannon Cox, MCR, BSN, RN, ETRA, Merck

• Kaitlyn Rhodes, MCR, ACRP-CP, Clinical Trial Coordinator (CTC), Merck

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Sharleen Traynor, PhD, MPH, Director, Clinical Trials Research Associate Program, Durham Technical Community College

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

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

Related Blog Content:

• Is ChatGPT Listening in On Your Next Informed Consent?

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Craig Garmendia, PhD, MS, Investigator, International Inspection Cadre, U.S. Food and Drug Administration

Related Blog Content:

Getting Ahead of Tech-Related Data Integrity Challenges

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Jennifer McLeland, PhD, CCRC, ACRP-PM, RPSGT, Manager, Division of Clinical Research, Washington University School of Medicine

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.

CEU: 1.00 ACRP

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

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

Vatche Bartekian, President, Vantage BioTrials

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

• Kathleen Kane, MBA, CCRP, Senior Manager, Clinical Operations, NMDP

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speakers:

• Krista Kachnik, BS, Clinical Research Coordinator, The Spine Network

• Marcus Stone, PhD, Principal, The Spine Network

Watch a Sneak Peek 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:

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

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

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

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

Join us in the Expo Hall from 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.

Signature Series Session

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. 

CEU: 1.00 ACRP

Speaker:

David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Related Blog Content:

The Transformation of Trial Design and Conduct

Network with your community and enjoy morning coffee in the Platinum Ballroom before and during our Signature Series session.

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.