This package is a replay of 21 on-demand session recordings and presentation slides from the Innovation & Change Management Track at the ACRP 2026 Conference, April 24 – 27, Orlando, Florida. Offers clinical research leaders and teams the insights and best practices needed to foster innovation and lead change management in clinical research.
Member: $99 | Nonmember: $149
Participants can earn up to 21 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Learning Portal.
Artificial intelligence (AI) is transforming clinical research by streamlining patient identification, automating data capture, and enhancing imaging analysis. This session explores practical applications of AI in oncology trials, focusing on three high-impact areas: 1) patient matching and identification using advanced algorithms to accelerate enrollment and improve diversity; 2) seamless data collection through integration from electronic medical records to electronic data capture, reducing manual errors and increasing efficiency; and 3) automated imaging analysis, such as AI-driven RECIST measurements, to improve consistency and speed in response assessments. Attendees will take away actionable insights and learn from real-world examples for implementing AI solutions while addressing challenges in adoption, data quality, and regulatory considerations. Speaker: Chelsea Osterman, MD, Executive Medical Director, Tempus AI
Artificial intelligence (AI) is revolutionizing clinical research by enhancing protocol generation, operational efficiency, and participant recruitment/engagement. Through predictive analytics and digital twins, AI streamlines protocols, optimizes inclusion criteria, and minimizes risk. AI also strengthens safety monitoring by identifying early adverse event patterns across diverse datasets, enabling proactive responses. For sponsors and sites, AI supports ongoing access to training and streamlines standard operating procedure development by analyzing past performance and recommending standardized practices. It automates data collection, reducing manual errors and accelerating timelines. In recruitment, machine learning matches ideal candidates using electronic health records and real-world data, while adaptive algorithms personalize recruiting messaging to improve enrollment rates. Together, these innovations reshape the trial landscape, making studies faster, safer, and more inclusive without compromising data integrity or participant protection. Examples reviewed include seen and unseen real-world AI impacts. Speakers: Alain Alvarez Legra, Director for Clinical Research Coordinators, Bolanos Clinical Research; Karen Lindsley, DNP, MSN, RN, CCRC, CDCES, Manager of Regulatory Knowledge and Support, Clinical and Translational Science Alliance of Georgia, Emory University
Clean data don’t just fall from the sky. They are the result of smart systems, agile teamwork, and strong protocol design. We’ll walk through real-world cases involving National Institutes of Health-funded clinical trials launched during the pandemic and adapted for decentralized and hybrid delivery models. Attendees will learn how to navigate complex databases even when study teams lack experience with Good Clinical Practice, design usable workflows from complicated protocols, and handle unexpected data management hurdles. We’ll share wins, near-misses, and lessons learned from integrating mobile apps, multiple electronic data capture platforms, Veterans Affairs systems, and real-time secure file transfer protocols. We’ll tie it all together using coordination science principles to show how better communication, shared understanding, and team alignment can lead to cleaner data and fewer deviations. Come for the strategy, stay for the stories, and leave with tools to clean up your own data chaos. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Jamie Dwyer, MD, Assistant Vice President for Clinical Research, University of Utah; John VanBuren, PhD, Senior Faculty Biostatistician, University of Utah
Too few research organizations (e.g., sponsors and sites) have access to the large and diverse populations that primary care organizations (PCOs) and their healthcare professionals serve. This session will bring forth the results and easy-to-use, action-oriented tactics from the first-of-its-kind “Research in Primary Care Action Roundtable,” which included participants from PCOs, study sponsors, and study sites. PCOs are a healthcare entity focused on delivering first-contact, comprehensive, and continuous care to individuals and families across all ages, genders, and health conditions. They care for more than 100 million people in the United States, yet clinical trial access and participation through them continue to be seen at minimal levels. A shared vision is to build a movement to make clinical trials mainstream in support of healthcare’s pivot toward value-based care, and to provide research organizations with access to large and diverse populations leading to more efficient, representative, and accelerated study enrollment. Speakers: Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech; Osa Eisele, MD, MPH, Executive Director and Head of Representation in Clinical Research, Amgen; Pete Fronte, MBA, President & CEO, Altura; Rakesh Patel, MD, MBA, FACHE, CPE, CEO, Neighborhood Healthcare
Minoritized populations have historically been underrepresented in clinical trials. Speakers for this panel from a research center located in an underserved California community that is 80% Latino have found that observational trials—when strategically implemented—can build trust and engagement. Panelists will share their experiences with an Alzheimer’s disease observational study that became a catalyst for broader community involvement. The site achieved top-three national enrollment, increased Latino participation, and fostered partnerships with local community centers and adult day programs. The effort significantly improved health literacy and facilitated acceptance of interventional Alzheimer’s trials. The center’s site director, manager, study coordinator, pre-screener/recruiter, and community engagement representatives will highlight key strategies across all stages of the trial, demonstrating how observational studies can enhance community engagement, reduce stigmas related to trial participation, and lay the foundation for future research. Speakers: Emilia Alcala, Clinical Research Coordinator, Sun Valley Research Center; Leslie Michelle Dowling, Site Manager, Sun Valley Research Center; Judy Galindo, CCRC, Executive Director & Site Co-Owner, Sun Valley Research Center; Vanessa Nuño, Community Engagement Representative, Sun Valley Research Center
As clinical research evolves, sites are challenged to streamline workflows while upholding rigorous regulatory standards. This presentation outlines an evidence-informed approach to modernizing research conduct through informatics and digital tools. The session will deliver actionable strategies for integrating computerized systems into clinical research infrastructure—including electronic source documentation, e-regulatory platforms, and billing compliance automation. The session will explore key performance indicators to assess site health, lessons learned from multisite consultations, and practical guidance for regulatory alignment across varied geographic regions. Emphasis will be placed on optimizing research operations in academic settings, promoting digital transformation, and fostering global collaboration. Attendees will gain tools to assess and enhance site-level research operations; implement informatics systems that support regulatory integrity; and align compliance strategies with evolving state and federal guidelines. This session is ideal for clinical research professionals, site directors, and compliance specialists seeking to advance digital integration and sustain high-functioning research programs. Speaker: Candida Barlow, PhD, MSN, CRN-BC, RN, Director Clinical Research, Oklahoma State University Center for Health Sciences
The emergence of decentralized clinical trials (DCTs) has reshaped the way we approach execution of clinical trials requiring few or no face-to-face touchpoints with patients. A successful DCT requires a different operational infrastructure, different technology, and different personnel from a traditional clinical trial. This session offers a practical, end-to-end toolbox for designing and operationalizing DCTs. Attendees will learn actionable strategies for protocol design that allow remote workflows and patient-centric recruitment. We will discuss common pain points that contribute to attrition in DCTs and strategies for prevention. The session will review approaches for building and leading remote teams and for leveraging technology to improve efficiency of remote work. Finally, we will discuss the role of the principal investigator, research coordinator, and data manager as they are deployed in a decentralized fashion. This talk is for those interested in launching DCTs and for those running DCTs who want to expand their capabilities. Speakers: Kimberly Lamberti, PhD, Senior Clinical and Regulatory Affairs Specialist II, Nilo Medical Consulting Group; Marianne Parrish, MPH, Clinical Project and Data Manager, Nilo Medical Consulting Group
Sponsors are revolutionizing the site experience by leveraging artificial intelligence (AI) to develop a survey automation tool, significantly simplifying the site feasibility survey process. This tool aims to reduce administrative burdens, enhance data accuracy, and provide real-time support, making it easier for sites to participate in clinical trials. Beyond current metrics, AI is also employed to identify the best-fit sites by creating an optimal potential site list based on extensive priorities. This includes tiering sites according to past performance, quality, and proximity to diverse catchment areas. By integrating these advanced AI-driven techniques, sponsors ensure that the site selection process is efficient, inclusive, and of the highest quality. These efforts not only streamline operations but also foster stronger collaborations with sites, ultimately advancing clinical research and improving patient outcomes. Speaker: Bonnie Lam, Feasibility, Strategy and Analytics Lead, Pfizer Inc.
Sites are overwhelmed by the increasing number and complexity of technology solutions required to execute clinical trials. This is exacerbated by the increasing number of solution providers selected. Currently, research sites are typically required to use sponsor-provided technology systems. The Decentralized Trials and Research Alliance’s (DTRA’s) “Bring Your Own Technology” initiative aims to enable clinical research sites to use their own validated technology systems in industry-sponsored clinical trials while maintaining regulatory compliance and sponsor oversight. The objective is to reduce operational inefficiencies, improve data quality, and enhance site and patient experiences. This session will share the work done by DTRA to date to define a process to enable adoption of site-preferred technology in registrational trials. Using eConsent as a model, key considerations and impact assessments conducted to identify opportunities and challenges from a multi-stakeholder perspective will be shared. The work continues in 2025-26, focusing on site-preferred eSource adoption by sponsors. Speakers: Joe Dustin, Founder and Principal, Dauntless eClinical Strategies; Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions
Artificial Intelligence (AI) is no longer a futuristic concept in clinical trials, it’s an emerging reality with real-world impact across design, recruitment, operations, and data analysis. This session presents insights from a multi-stakeholder working group exploring how AI is being applied in practice, what responsible use looks like, and what collective standards are needed to ensure adoption accelerates rather than fragments progress. Through interactive discussion and scenario-based exploration, participants will examine proposed practical frameworks for AI governance, definitions of responsible use, and baseline metrics for measuring AI’s effectiveness. The session will also outline regulatory engagement strategies and explore key global differences in AI oversight. Attendees will leave with tools to guide internal conversations, assess vendor claims, and contribute to shared industry alignment on AI in trials. Speakers: Andrea Bastek, Ph.D., VP of Market Strategy, Florence Healthcare; Victor Chen, Principal, The CK Clinical Group; Heather Manley, MS, LPC, Senior Site Director, JCCT
This session will provide key topics in keeping up with new monitoring techniques in the dynamic atmosphere of decentralized clinical trials. We will explore how to use modern systems and technology to aid in efficiency in monitoring both virtual decentralized clinical trial sites and brick and mortar sites participating in decentralized clinical trials. Topics examined will include a discussion of systems used in decentralized sites and decentralized trials, navigating these systems, and creating bespoke methods of monitoring to respond to novel models of clinical trials. Speaker: Jessica Carlson, BA, CCRA, Sr Clinical Research Associate, Apogee Therapeutics
The field of oncology clinical trials is dynamic and intricate, with continuous evolution introducing new challenges for research sites. This panel discussion features seasoned representatives from highly active research sites sharing their innovative strategies for navigating this evolving landscape. While universal solutions are elusive, each site employs a unique blend of technology and human expertise to achieve its research objectives. Speakers: Meghan Degele, Sr. Director, Tempus AI; Tiffany Kirkpatrick, PharmD, ACRP-CP, Cancer Research Quality Program Manager and Research Pharmacist, Avera Cancer Institute; Ashley Servais, Director of Clinical Research, Nebraska Cancer Specialists; Alexis Wilson, Research Clinical Operations Coordinator, MemorialCare
Technology rollouts in clinical research struggle when change isn’t managed effectively. This session explores how to lead successful transitions to site-based eClinical solutions like electronic investigator site files, electronic source, and participant engagement platforms. The session will highlight common pitfalls in site-level implementations and how to avoid them through proactive communication, pilot workflows, and leadership alignment. Designed for site leaders and operations professionals, the session focuses on practical, real-world strategies for overcoming resistance, fostering cross-functional buy-in, and building adoption plans that last beyond go-live. Attendees will walk away with a clear framework on how to engage stakeholders early, design training that sticks, and track meaningful adoption metrics. Speaker: Alicia Gearhart, Director of Professional Services, RealTime eClinical Solutions
This session will delve into the critical role of academic medicine in clinical research, exploring why it is considered the pinnacle of clinical trials. We will discuss the historical and current challenges faced by academic researchers and how they are navigating the modern clinical trials environment. The session will review the impact of startups, technology, data, patient engagement, and newer political challenges on medical research. We will also identify solutions for current bottlenecks in academic research and propose strategies for moving forward and thriving in the current environment. Attendees will gain valuable insights into the evolving landscape of clinical research and the innovative approaches being employed to overcome obstacles. The session will conclude with a Q&A segment, allowing for an interactive discussion with the audience. Speaker: Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center
Clinical trial recruitment faces persistent challenges, including prolonged enrollment periods, high screen failure rates, and inconsistent data quality. This session introduces the innovative block enrollment strategy, which accelerates trial recruitment by concentrating all site resources on a single protocol during a focused enrollment period. By aligning the entire research team and optimizing patient engagement, the block enrollment approach improves enrollment efficiency, reduces screen failures, and enhances participant retention. Drawing on real-world data from ophthalmic trials, attendees will explore how this model streamlines workflows while maintaining rigorous quality standards. The session will engage participants in discussing scalability and adaptation of block enrollment across various therapeutic areas. Key roles of principal investigators, study coordinators, and support staff in this focused recruitment method will be highlighted. Attendees will have the opportunity to learn about a transformative, practical approach that reshapes clinical trial enrollment and optimizes site performance. Speaker: David Almeida, MD, MBA, PhD, President and CEO, Centers for Advanced Surgical Exploration (CASEx) and Erie Retina Research
Clinical research is often seen as a risk-averse industry, but is that perception accurate? This interactive session challenges the assumption that traditional choices are inherently safe. Through real-world case studies and a behavioral risk framework, we’ll explore how decisions around protocol design, site selection, technology adoption, and feasibility often mask high operational risk under the guise of caution. Attendees will examine how “playing it safe” can lead to protocol amendments, recruitment failures, and delays, and learn how to use Quality by Design (QbD) and ICH E8(R1) principles to anticipate and mitigate these outcomes. The session includes audience polling, risk-mapping exercises, and practical tools to identify where organizations may be unintentionally risk-seeking. Whether you’re in study startup, clinical operations, or site management, you’ll walk away with actionable strategies to reframe risk, support better decision-making, and challenge the illusion of safety that drives costly inefficiencies in clinical trials.
Speakers: Mitchell Hilbe, CEO / Co-Founder, DiversiTrials; Jess Thompson, CEO, Clinical Research Pro; Jami Walker, Clinical Operations and Management, Mead Johnson
Clinical research is undergoing a dynamic transformation—propelled by breakthrough developments, evolving regulations, and fresh approaches to collaboration. David Burrow will offer strategic insights on elevating trial quality and minimizing regulatory uncertainty—sharing forward-thinking approaches and practical tools designed to help research professionals thrive in today’s complex and rapidly shifting environment. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, U.S. Food and Drug Administration
Manual data entry drains site resources and delays trial timelines, especially as studies grow in complexity, volume, and number of sources. However automated electronic health record-to-electronic data capture (EHR-to-EDC) integration can dramatically reduce site burden when it’s designed with usability in mind. This session explores what it really takes to make eSource and EHR-to-EDC work for sites: no new systems, no additional logins, no information technology support—just streamlined, intuitive workflows that fit naturally into how research coordinators already work, drawing on experiences from dozens of oncology trials across academic and commercial research settings. Attendees will gain actionable insights on how EHR-connected workflows can save time, reduce errors, and improve monitoring through traceable data capture, plus practical best practices for improving execution, supporting smarter source data verification, and scaling eSource without added complexity. Speakers: Samir Jain, VP, Product Management, Healthcare Data Interoperability and EHR Solutions, Medidata, Dassault Systemes; Milijana Ugrenovic-Petrovic, Senior Director, Clinical Trials Office, Moffitt Cancer Center
The advancement and rapid utilization of artificial intelligence (AI) scribes and other AI assistant tools in the clinical space raise new questions about what constitutes “source” for data in healthcare settings. During this discussion, we will look at AI scribe programs that are currently being used at major hospitals and clinics across the U.S. in order to identify concerns, discuss mitigations, and better understand what should be considered when conducting site qualification visits from a quality management perspective. For example, what is the source when the original records/transcripts are not maintained? What is the role of investigators in ensuring accurate, artificially created notes and care plans? Does the institution have plans in place to ensure data integrity in the age of AI-generated notes? Speaker: Michele La Badie, ACRP-CP, ACRP-MDP, ACRP-PM, Clinical Trial Manager, Shoulder Innovations
This session will delve into how sponsors develop effective recruitment strategies for clinical trials, emphasizing the practical impact of these tactics. Attendees will gain insights into how feedback from clinical sites is utilized by sponsors to craft creative and adaptive recruitment approaches. The session will highlight real-world examples and case studies to illustrate the success of these strategies in enhancing participant engagement and trial efficiency. Speakers: Simranjit Mehta, Recruitment Strategist, Pfizer; Nikki Thomas, Recruitment Strategist, Pfizer
This session will highlight the transformation of protocol activation and lifecycle management that results in improved research billing compliance, streamlined workflows, aligned financial policies, and enhanced training curriculum. Despite the complexity of study activation, we found that mastering the basics—clear policies and procedures along with practical tools—was key to success. Attendees will leave with strategies and tools to confidently support clinical trial workflow transformation projects. Speakers: Chad Eriksen, MS, CCRC, FACRP, President, Strategic Advisor / Sr. Project Manager – Yale Center for Clinical Investigation (YCCI) Iron Horse Research; Kayleen Joyce, MS, CCRC, ACRP-PM, Consulting Manager, Huron Consulting Group