This package is a replay of 14 on-demand session recordings and presentation slides from the Clinical Operations Track at the ACRP 2026 Conference, April 24 – 27, Orlando, Florida. Offers clinical research leaders from Sponsors and CROs the insights and best practices needed to effectively plan and manage clinical trials.
Member: $99 | Nonmember: $149
Participants can earn up to 13 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Learning Portal.
Back by popular demand and reimagined for 2026, the ACRP Game Show returns with more energy, more surprises, and more chances to test your knowledge in this high-energy session. Teams of clinical research professionals will go head-to-head in a fast-paced trivia battle covering everything from ICH-GCP principles to eClinical technology, informed consent essentials, and more! Audience members won’t just watch—they’ll play along, cheer on their peers, and maybe even walk away with bragging rights. Whether you’re a seasoned expert or a curious newcomer, this session is your chance to learn, laugh, and celebrate the clinical research enterprise in a whole new way. Speakers: Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen; Lexi Herbert, Launch Manager, TrialScreen
This dynamic session explores the complexities and opportunities of conducting clinical research outside the United States. Through real-time polling, interactive Q&A, and scenario-based reflection, attendees will gain practical insights into regulatory, cultural, and operational differences across global regions. The session will equip clinical research professionals with tools and strategies to confidently engage in multinational trials, while promoting inclusion, equity, and global collaboration. Speaker: Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy
As clinical research grows more complex and data-driven, patient-centered risk management is essential to designing resilient trials. This panel explores a holistic, ICH E6(R3)-aligned approach that embeds risk mitigation across the trial lifecycle while prioritizing patient needs, safety, and experience. Panelists will share real-world examples of how inclusive protocol design and patient advisory input during early planning reduce risk by improving accessibility, engagement, and retention. In startups, automated site selection and harmonized regulatory workflows minimize delays and variability, accelerating patient access. Artificial intelligence-based image sharing and interpretation require validated, explainable models and human oversight as key risk mitigation strategies to safeguard outcomes. Predictive analytics, risk-based monitoring, and centralized oversight tools help identify early warning signals and enable timely intervention. By embedding holistic risk mitigation with patient-centered operational strategies, innovation, and oversight, this session highlights how to build trials that are not only compliant and efficient, but also resilient and responsive. Speakers: Lourdes Carhuapoma, PhD, CRNP, Director, Participant-Centered Research Integrity and Risk, Johns Hopkins University, BIOS Clinical Trials Coordinating Center; Lindsay Eyzaguirre, MS, Assistant Professor, Johns Hopkins University School of Medicine; Clinical Coordinating Center Director, BIOS CTCC; Project Lead, Johns Hopkins University Trial Innovation Center (JHU TIC), Johns Hopkins University, BIOS Clinical Trials Coordinating Center; Karen Lane, CCRP, Assistant Professor of Neurology, Johns Hopkins University Deputy Director, BIOS Clinical Trials Coordinating Center Director, Multicenter Study Operations Training Program, ICTR MPI, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center; Andrew Mould, MPH, Assistant Professor, Department of Neurology; Data Coordinating Center Director, BIOS CTCC; HEAL Director, JHU SSRC HEAL Pain ERN; Assistant Director, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Clinical research teams manage millions of data points and thousands of documents—yet many still rely on manual, time-consuming processes that slow progress and increase risk. The good news: There are accessible AI and automation tools within your office suite that can significantly streamline everyday tasks. Join experts in clinical research operations as they share practical use cases, share insights, and discuss how you can build confidence and expertise in this rapidly changing field. Specific topics include reducing the AI fear factor, building an AI-informed workforce, and tackling clinical research operations with AI. Speakers: Burak Aktan, Head of Business Operations, Clinical Sciences and Study Management, Merck; Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus; Andrew Gordesky, Regional Director, Clinical Quality Management Latin America, Merck; Sandra Koseoglu, Director/ Program Lead, Clinical Sciences and Study Management, Merck; Chelsea Osterman, MD, Executive Medical Director, Tempus AI; Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, Merck; Jennifer Sheller, ACRP-CP, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck; Karen Strat, PhD, Clinical Scientist, Merck
This session will explore the critical role of Data Management (DM) in coordinating database lock activities across key stakeholders, including sites, sponsors, clinical operations, vendors, and biostatistics. A smooth database lock is vital to ensure data integrity and timely study reporting. From the DM perspective, we will outline the end-to-end process, emphasizing proactive planning, clear communication, and the use of customized tools that streamline collaboration and mitigate delays. Strategies such as freeze readiness checklists, data reconciliation trackers, and query management processes will be discussed to illustrate how efficiencies can be built into the process. By the end of this session, attendees will understand common pitfalls and effective solutions, as well as approaches to deliver an on-time and accurate database lock. Speaker: Abby Loden, MPH, Lead Data Manager, TRiNDS LLC.
Protocol deviations, if not properly identified and addressed, can jeopardize participant safety, data integrity, and trial credibility. The FDA’s December 2024 draft guidance on “Protocol Deviations for Clinical Investigations” introduces clearer expectations around assessing, categorizing, and reporting deviations, especially those deemed “important.” This session will provide attendees with a practical framework to align their practices with the evolving regulatory landscape. Through real-world case scenarios and an interactive exercise, participants will learn how to evaluate deviations using a risk-based approach and strengthen communication with institutional review boards and sponsors. We will also analyze emerging tools, including automation and artificial intelligence, that support proactive deviation detection and inspection readiness. Designed for clinical operations teams, site staff, and quality assurance professionals, this session combines compliance essentials with forward-looking strategies. Speakers: Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training; Meghana Rao, Sr. Manager, Clinical Trial Lead, Olema Oncology; Kaushal Shah, PhD, Director & Clinical Associate Professor, Clinical Research Management & Regulatory Science Programs, Arizona State University
The value of engaging non‑traditional and emerging sites is widely recognized, yet many of these sites continue to be overlooked due to a lack of prior trial experience. This creates a persistent cycle: sites struggle to build experience without access to studies, while sponsors often prioritize experience when selecting sites—ultimately limiting broader representation in clinical trials. With funding from Roche | Genentech, Duke Clinical Research Institute, and National Medical Fellowships, and support from Continuum Clinical, ACRP and its collaborators will share preliminary findings from qualitative interviews with sponsors and non‑traditional sites. These insights highlight real‑world barriers to participation in Phase III studies. Attendees will gain practical insight into how rethinking site selection—and more intentionally engaging non‑traditional sites—can support stronger recruitment outcomes while advancing meaningful representation. Speakers: Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech; Laveina Dash, Director, Doctors in Clinical Trials Research (NMF DCTR), National Medical Fellowships; Pete Fronte, MBA, President & CEO, Altura; Karen Lipworth, Communications Strategist and Senior Medical Writer, ACRP; Kathy Mickel, Director of Membership & Programs, Society for Clinical Research Sites; Susan P. Landis, Chief Executive Officer, ACRP (Moderator)
Decentralized clinical trials are reshaping how research is conducted, offering new opportunities to expand access, improve participant accrual, and reduce the burden on limited organizational resources. This session will explore transformative approaches institutions can take to implement and manage decentralized trials effectively. Attendees will learn how to adopt flexible models that support research growth without requiring extensive staffing or infrastructure. The session will highlight practical strategies for integrating decentralized elements into existing workflows, including virtual visits, digital tools, and participant-centered processes. Real-world examples will show how organizations have successfully used decentralized models to reach underserved populations and streamline operations. Whether the organization is beginning to explore decentralized research or looking to scale existing efforts, this session will provide actionable insights to help align trial design with institutional goals. Attendees will discover how decentralized research can be a powerful tool for increasing efficiency, expanding reach, and supporting sustainable research operations. Speaker: Shreya Singh, Consulting Sr. Associate, Huron Consulting Group
For years, the clinical research industry has pursued transformative changes—seeking smarter trials, more efficient processes, and improved patient outcomes. Today, those long-awaited advancements are no longer aspirational—they’re happening. From decentralized trials and AI-driven insights to streamlined protocols and enhanced patient engagement, the future of clinical research is unfolding in real time. Speakers: Barbara Bierer, Faculty Director, Harvard Medical School; Kevin Bugin, Associate Vice President of Global Regulatory Policy and Intelligence, Amgen; Rob DiCicco, Vice President of Portfolio Management, TransCelerate Biopharma Inc; Morgan Hanger, Executive Director, Clinical Trials Transformation Initiative; Jennifer Byrne, Chief Executive Officer and Board Director, Javara (Moderator)
Clinical research is a dynamic field shaped by the people who plan, conduct, and oversee it at every career stage. This engaging panel brings together diverse voices to share their career journeys, the leadership skills that fueled their growth, and the pivotal moments that defined their paths. Speakers: Michelle Rowe, RN, VP, Research, HCA Healthcare; Jennifer Sheller, ACRP-CP, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck; Muriel Maignan Wilkins, CEO & Founder, Paravis Partners; Susan P. Landis, Chief Executive Officer, Association of Clinical Research Professionals (Moderator)
Study startup delays represent a critical barrier impairing efficiency in clinical research timelines and our ability to ultimately serve patients. Tackling each contributing factor in this issue should be an effort we all engage in. The Site-Sponsor Consortium—a unique collaboration of sponsors, contract research organizations, institutional sites, and commercial sites—will unveil its inaugural whitepaper, which details actionable strategies to simplify and harmonize Confidentiality Disclosure Agreement processes across the industry. Consortium members will discuss the operational and ethical imperatives for reform, the value of master and bilateral agreements, and the collaborative journey that led to consensus-driven solutions. Attendees will gain insight into the practical steps needed to reduce study startup timelines and foster a culture of shared responsibility, transparency, and innovation in clinical research. Speakers: Carlos Orantes, Chief Executive Officer, Alcanza Clinical Research; Michelle Rowe, RN, VP, Research, HCA Healthcare; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra; Brandi Walker, Executive Vice President, Clinical Development Operations, Syneos Health
Strong collaboration between contract research organizations (CROs) and study sites is essential for reducing trial delays, improving data quality, and accelerating patient access to new therapies. This panel, designed for clinical research professionals in operations, monitoring, study startup, and site roles, explores how intentional collaboration between CROs and study sites can drive measurable improvements in operational efficiency and data quality. Panelists will share real-life case studies and practical examples that highlight strategies for streamlining study startup, reducing rework, and building trust. Attendees will gain forward-thinking insights and walk away with actionable tips, tools, and processes to strengthen site-CRO relationships and enhance trial success. Join us to explore how shifting from reactive problem-solving to proactive partnership can transform site-CRO relationships into high-impact alliances that advance research and patient care. Speakers: Elizabeth Feathers, Clinical Operations Supervisor, Study Startup, CIBMTR; Kassandra Nealon, BS, Clinical Operations Manager, CIBMTR
Clinical trial recruitment often fails not because patients do not exist, but because they are never identified. Specialty private practices hold large, underutilized patient populations, yet recruitment strategies still rely on static feasibility surveys and manual chart review. This session introduces a data-driven approach that begins with a retroactive audit of existing patient records to quantify true trial feasibility, followed by real-time identification of eligible patients directly within clinical workflows. By structuring both structured and unstructured EHR data, sites can surface eligible patients continuously without manual effort. Using real-world deployments, we will show how this model replaces guesswork with measurable patient availability, reduces screening burden, and enables faster, more predictable enrollment. The result is a shift from reactive recruitment to a continuous system aligned with how care is actually delivered. Sponsored by Syntra. This session does not provide ACRP Contact Hours. Speakers: Ayush Jain, Co-Founder and CEO, Syntra; Eshanika Urs, Founding GTM, Syntra
Research teams are being asked to do more with less—especially when it comes to unfunded or underfunded studies. Whether it’s supporting investigator-initiated trials with no startup budget or absorbing hidden costs from sponsor studies, the financial strain is real. This session offers practical strategies for identifying and managing financial risk at the site level. We’ll walk through tools for feasibility screening, cost recovery, and portfolio-level decision-making. Attendees will leave with insights they can use to engage investigators and institutional leaders in honest conversations about what it really costs to “just get it done.” Speaker: Shannon Chism, Education & Research Consulting Sr. Director, Huron Consulting Group