The registration desk is your go-to resource for questions, assistance, or anything you need throughout ACRP 2027.

Stop by the Pacific Foyer for help with your conference badge, materials, or navigating your conference experience in San Diego.

Start your day in the Expo Hall with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.

Session and speaker details coming this fall!

Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this extended networking break.

Human gene therapy trials may require clinical research teams to coordinate two distinct but connected oversight processes: institutional review board (IRB) review and institutional biosafety committee (IBC) review. When teams are unclear on how these reviews differ, where they intersect, or when coordination should occur, study start-up can stall.

This session will clarify the IBC’s role in assessing biosafety risks, containment considerations, and institutional responsibilities while showing how coordinated IBC–IRB review can support participant safety, ethical oversight, and efficient study start-up.

Attendees will examine practical collaboration points across submission planning, review sequencing, communication, amendments, and ongoing safety oversight. Using real-world operational scenarios, the session will help site, regulatory, and study management professionals recognize avoidable delays, close oversight gaps, and build more connected review workflows for human gene therapy and engineered genetic material research.

CEU: 1.0 ACRP

Speaker:

James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra

Efforts to improve enrollment and representation in clinical trials must go beyond recruitment tactics to address systemic barriers, mistrust, and lack of awareness.

This session presents real-world case studies from community engagement efforts undertaken from 2023 to 2026 in dozens of cities across the U.S., showcasing how community-centered partnerships can drive meaningful and lasting engagement and measurable impact.

The session draws on mobile exhibits and community event engagements held, for example, at farmers and food markets, historically black colleges and universities, cultural festivals, and health fairs. These initiatives fostered dialogue and sustained interest, with impact metrics revealing significant increases in understanding of and willingness to participate in clinical research.

One speaker from a nonprofit organization and two research sponsor representatives will share testimonials from stakeholders and insights on designing and executing inclusive engagement strategies, co-developing culturally responsive materials, and collecting operational key performance indicators to inform future engagement.

CEU: 1.0 ACRP

Speaker:

• Behtash Bahador, Senior Director, Community Engagement & Partnerships, Center for Information and Study on Clinical Research Participation, Inc. CISCRP

Clinical research coordinators face data-entry challenges that go far beyond "copy and paste." A single lab value from one report often needs to be entered into three or more separate electronic case report forms. A source document reports an exact number, but the form asks for a range. Units in the electronic health record (EHR) don’t match what the electronic data capture (EDC) system expects. And buried in pages of physician notes is the one clinical detail needed for a single field. These tedious and error-prone tasks consume hours that could be spent with patients. Artificial intelligence (AI) is built for exactly these problems. This session breaks down the specific pain points of EHR-to-EDC data transfer and shows how AI handles each one: mapping one value to multiple forms, converting units, translating values to ranges, and parsing unstructured clinical notes.

CEU: 1.0 ACRP

Speaker:

• Tejasva Jaitly, Founding Engineer, Truco

Clinical trials are often described as complex, but complexity alone does not explain why some studies struggle more than others. Some trials are operationally fragile: small disruptions in staffing, scheduling, participant availability, caregiver involvement, vendor performance, budget assumptions, endpoint execution, or communication pathways can quickly lead to enrollment delays, protocol deviations, site fatigue, participant dropout, budget disputes, and data quality concerns.

This session will introduce an Operational Fragility Framework for identifying clinical trial risk before enrollment begins.

Attendees will learn how to apply the framework for recognizing when trial fragility emerges during feasibility, site selection, budget review, study start-up, and operational planning and then, using real-world clinical operations examples, how to distinguish between trials that are merely complex and trials that require enhanced operational mitigation.

CEU: 1.0 ACRP

Speaker:

• Tia Warrick, Chief Executive Officer, Lesous Consulting LLC

This session explores how professional credentials are perceived and valued within the clinical research workforce, drawing directly from a mixed-methods research study examining both employer and clinical research professional perspectives. Attendees will review how micro-credentials, professional certifications, academic degrees, and combinations of credentials influence hiring decisions, career advancement, and professional development. The session will highlight areas of alignment and disconnect between employer expectations and employee experiences. Attendees will gain insight into how credentialing decisions shape workforce development, equity, and career mobility in clinical research, as well as how data from surveys and focus groups can inform institutional and individual credentialing strategies. The session is designed for research staff, hiring managers, educators, and workforce development leaders seeking evidence-informed approaches to credentialing decisions.'

CEU: 1.0 ACRP

Speaker:

• Jessica Fritter, DHSc, MACPR, ACRP-CP, FACRP, Associate Clinical Professor & Director, Master of Clinical Research and Certificate Programs, The Ohio State University

Emerging biotechnology companies are increasingly required to launch complex clinical trials under aggressive timelines, constrained budgets, and lean internal infrastructures. Traditional operational models and rigid outsourcing structures can create inefficiencies that delay study start-up, slow decision-making, and hinder execution.

This session will explore how agile clinical operations strategies, fit-for-purpose resourcing models, and collaborative sponsor/contract research organization (CRO) partnerships can accelerate study start-up while maintaining quality and oversight. Drawing from real-world experiences across Phase I-III global clinical programs, attendees will gain practical and proactive approaches for improving cross-functional alignment, streamlining communication and governance, managing start-up risks, and implementing scalable operational models that support efficient trial execution in today’s evolving clinical development environment.

CEU: 1.0 ACRP

Speaker:

• Shaily Garg, CEO, Exact Clinical Research

Clinical research sponsors face increasing pressure to design studies that balance therapeutic innovation, commercial expectations, and regulatory requirements. Misalignment among these drivers can result in operational inefficiencies, poor evidence generation, delayed decision-making, and risk of program failure.

This session explores practical approaches to strengthening governance and oversight frameworks that enhance the quality and predictability of study execution.

Attendees will gain insights on implementing early cross-functional governance strategies, designing quality-focused oversight frameworks, and fostering transparency and communication across sponsor stakeholders.

CEU: 1.0 ACRP

Speakers:

• Sara Garbin, Clinical Development Manager, Philips

• Sara Trbojevic, PhD, Clinical Development Scientist, Philips

Future-proofing the clinical research enterprise begins with the professionals who power it, although they have long struggled with overlooked professional identities and contributions, inconsistent job classifications, and persistent turnover. Despite a widely accepted competency framework and innovative approaches to training, hiring, onboarding, and retention being available, clear pathways into roles across diverse site, sponsor, and  contract research organization settings remain elusive. Apprenticeships offer a proven, competency-based answer: industries across the economy use them to develop high-quality early talent and build durable pipelines. This session describes how a taskforce network enabled two academic medical centers to co-create two distinct but aligned employer-based apprenticeship models, leveraging the complementary strengths of each. Now in years two and three, both models point toward a more resilient future for early-talent development.

Speakers:

• Michelle Jenkerson, RN, BS, CCRC, RRT, CPFT, Associate Director, Center for Clinical Studies, Workforce Development, Institute for Clinical and Translational Sciences, Washington University Medicine

• Denise Snyder, MS, RD, FACRP, Associate Dean for Clinical Research, Duke University School of Medicine

• Sharleen Traynor, PhD, MPH, ACRP-CP, Program Director, Clinical Trials Research Associate Program, Durham Technical Community College

Clinical research professionals are increasingly exploring consulting careers and flexible professional pathways. However, transitioning from traditional employment into consulting can be challenging, with limited practical guidance on evaluating readiness, positioning expertise, generating opportunities, and navigating the realities of independent work.

This interactive panel session brings together experienced consultants from clinical operations, site operations, and quality oversight to provide candid, experience-based perspectives on consulting in clinical research.

Through facilitated discussion, audience polling, and a practical Consulting Readiness Assessment Tool, attendees will explore consulting realities, risks, and readiness considerations, including expertise alignment, independent thinking, adaptability, business development approaches, and delivery expectations.

CEU: 1.0 ACRP

Speakers:

• Suheila Abdul-Karrim, CCRA, FACRP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant, Auditor & Trainer

• Leslie Sam, CQIA, CSSBB, President, Leslie Sam and Associates, LLC

• Yamile Sanchez, MBA, ACRP-PM, CCRP, Clinical Research Consultant, iNet Advisory Group

Clinical research sites routinely lose revenue they rightfully earned—not from poor science, but from a fragmented flow of funds. Budgets, contracts, protocols, and financial activity are siloed, rarely reconciled, and nearly impossible to monitor in real time. This session introduces a practical end-to-end cost recovery framework that treats artificial intelligence (AI) as a budget reconciliation engine: systematically comparing what the institution agreed to do, what the sponsor agreed to pay, what the site expected to spend, and what actually occurred.

Attendees will map the most common failure points in the revenue lifecycle, examine where reconciliation typically breaks down, and leave with actionable strategies they can implement immediately. Particular attention will be given to scalable and equitable approaches that serve institutions of all sizes, ensuring that stronger financial infrastructure translates directly into reinvestment in the research mission.

CEU: 1.0 ACRP

Speaker:

• Shreya Singh, Senior Associate, Huron Consulting Group

• Eric Tomasini, Managing Director, Clinical Research Solution Leader, Huron Consulting Group

What happens after a U.S. Food and Drug Administration (FDA) inspection can affect regulatory risk, business continuity, and compliance in clinical trial settings. This session will explain the FDA’s post-inspection process and outcomes, including FDA Form 483 (Inspectional Observations), Establishment Inspection Reports, Untitled Letters, Notice of Initiation of Disqualification Proceedings and Opportunity to Explain letters, and determinations of No Action Indicated, Voluntary Action Indicated, and Official Action Indicated.

Attendees will learn how the Agency evaluates findings, reviews responses, and decides next steps, and will gain a practical understanding of the key documents issued at the end of an inspection and FDA decisions that can lead to Warning Letters or enforcement. With a focus on root cause analysis and Corrective and Preventive Action Plans, this session will explain what each outcome means from regulatory and operational perspectives, helping attendees anticipate risk, prioritize responses, and communicate effectively across teams. Attendees will leave with practical strategies and greater confidence in managing observations, reducing escalation risk, and improving inspection readiness.

CEU: 1.0 ACRP

Speaker:

• Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer, Holwell Clinical Research Consulting

Artificial intelligence (AI) tools are increasingly being used across clinical trial workflows for note drafting, protocol summarization, communication support, document review, and operational assistance. However, many clinical research professionals remain uncertain about how HIPAA, confidentiality obligations, sponsor agreements, and privacy expectations apply when using these technologies in daily research activities.

This session provides a practical discussion of common AI-use scenarios encountered across sites, contract research organizations, sponsors, and institutional review boards. Through real-world examples and interactive audience discussion, attendees will explore where privacy and confidentiality risks may emerge and how to recognize operational red flags before inappropriate disclosure occurs, helping them build safer habits for AI use within clinical research environments.

CEU: 1.0 ACRP

Speaker:

• Sahar Zahid, MD, Graduate Student, Arizona State University

An exclusive, invitation-only event honoring the 2027 Class of Fellows and offering a special opportunity to connect with peers.

Break for lunch and keep moving in the right direction—connect with your community, reflect on your top takeaways, and discover solutions from 50+ trailblazing organizations throughout the Expo Hall.

Clinical research coordinators are facing unprecedented burnout, largely driven by the tedious, manual data transcription between electronic health record (EHR) and electronic data capture (EDC) systems. To address this operational crisis, a recent study directly quantified the impact of EHR-to-EDC automation on site staff’s mental workload. This session will reveal real-world data demonstrating how seamless integration slashes cognitive load, reduces task-related frustration, and reclaims critical hours per patient visit. Attendees will discover how alleviating this administrative fatigue directly empowers coordinators to reallocate their energy toward patient care and protocol compliance. Finally, actionable strategies will be outlined for sites and sponsors to leverage interoperability tools as a strategic weapon against coordinator turnover.

CEU: 1.0 ACRP

Speaker:

• Samir Jain, Head of EHR and Interoperability Solutions, Medidata, a Dassault Systèmes company

Back for its third year, the ACRP Game Show brings clinical research knowledge to life through fast-paced competition, audience participation, and a healthy dose of fun. Teams of clinical research professionals will go head-to-head in a lively trivia showdown covering topics such as ICH-GCP principles, eClinical technology, informed consent, regulatory requirements, and other key areas of the profession.

But the action is not limited to the stage. Audience members are encouraged to play along, test their own knowledge, cheer on their colleagues, and see how they stack up against fellow attendees as the competition unfolds. With unexpected twists, friendly rivalry, and opportunities to learn along the way, every round keeps participants engaged.

Whether you are a seasoned professional or new to clinical research, come ready to challenge yourself, join the conversation, and enjoy an interactive session that combines learning, teamwork, and plenty of fun.

CEU: 1.0 ACRP

Speaker:

Elisa Cascade, MBA, FACRP, Chief Growth Officer, TrialScreen

Clinical research does not end when a protocol is executed, data are cleaned, or a study report is complete. This session introduces medical communications as a practical, cross-functional bridge between clinical operations, evidence generation, technology platforms, and the patients and professionals the research is meant to serve. Using real-world, noncommercial examples, attendees will examine how study teams can plan for evidence translation earlier in the research lifecycle, connect trial execution decisions to downstream communication needs, and use integrated tools and workflows to improve clarity, consistency, and reach.

Panelists for this session will emphasize how attendees can partner with colleagues from other realms of stakeholders in the research to craft effective communications without compromising scientific rigor, compliance, or operational quality. Attendees will leave with a replicable framework for turning well-run research into credible, accessible, and actionable evidence.

CEU: 1.0 ACRP

Speakers:

• Maureen Jahraus, BS, MBA, Global Head, Medical Communications, Resmed

• Fatima Sert, PhD, Director Clinical Research, Americas, Resmed

The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practie fundamentally reframes the role of principal nvestigators (PIs) in clinical trial oversight—moving beyond task delegation to genuine, demonstrable accountability. Yet across sites and institutions, the most common response to E6(R3) has been procedural: updating the Delegation of Authority log and moving on.

This session challenges that approach. Drawing on real-world monitoring and audit scenarios across Phases I–IV, this advanced session examines what genuine PI oversight looks like in practice—and where the gaps between regulatory intent and site-level execution create the most significant compliance risk.

Topics include the distinction between task delegation and oversight delegation, PI accountability for data integrity and safety reporting, and how sites can build infrastructure that makes PI oversight visible, documentable, and sustainable under E6(R3) scrutiny. Attendees will leave with a framework for translating E6(R3)'s strengthened investigator requirements into operational site standards.

CEU: 1.0 ACRP

Speaker:

• Andrea Arruda, Principal Consultant & Founder, pharmaDev Consulting

Mentoring in clinical research is often misunderstood as a formal, structured program featuring matched pairs, monthly meetings, and a checklist of milestones. But the most transformative mentoring relationships rarely look like that. They happen across unexpected boundaries: a leader who sees potential before the mentee does, a difficult boss who inadvertently teaches everything about integrity, a trusted advisor from outside the field who asks the questions no one inside it will.

This session challenges clinical research professionals to expand their definition of mentoring—as both recipients and providers of guidance. Drawing on real-world examples across career stages and settings, attendees will explore what makes mentoring relationships effective, how to intentionally cultivate them, and how to become the kind of mentor the next generation of clinical research professionals actually needs. Attendees will leave with practical tools to identify, build, and sustain mentoring relationships that advance both individuals and the field at large.

CEU: 1.0 ACRP

Speaker:

• Leslie Pimentel-Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital

Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this extended afternoon networking break.

Launching a medical device clinical trial for a U.S.-based sponsor in a different global region requires more than regulatory approval and site selection. It requires practical coordination across sponsor teams, local site leadership, investigators, monitors, vendors, and study operations teams. Through a case study approach, panelists for this session will examine the start-up of a multisite medical device study in Saudi Arabia, from feasibility and site qualification through site initiation, activation, screening, and early enrollment. Panelists will discuss what worked, what required adaptation, and what clinical operations teams should consider when executing studies across geographies, cultures, time zones, and healthcare systems. Attendees will leave with practical lessons on site readiness, communication cadence, role clarity, patient recruitment, issue escalation, and sponsor-site collaboration in global medical device trials.

CEU: 1.0 ACRP

Speakers:

• Muath AlGhamdi, Clinical Research Specialist, Trial Forward

• Ryan McFadden, Lead Clinical Research Associate, Dexcom Inc.

• Kunal Sampat, Founder & CEO, Trial Forward

The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice is reshaping expectations for site readiness, documentation, and access to trial records. This session will prepare clinical research professionals to distinguish between routine interim monitoring visits, audits, and inspections, and to understand what their respective expectations mean in practice. Attendees will review what remains foundational, including timely institutional review board reporting, documentation readiness, and investigator site file maintenance, while examining areas of increased emphasis such as electronic system validation, audit trails, direct access to source documents and site facilities, and inspection-ready processes.

The session will also address practical considerations for pre-study visits, site initiation visits, and interim monitoring visits, including what site teams and partners should confirm before monitoring, audit, or inspection activity occurs. Attendees will leave with a clearer framework for preparing sites, identifying readiness gaps, and supporting compliant, well-documented clinical trial conduct.

CEU: 1.0 ACRP

Speaker:

• Lella Baker, Sr. Consultant, GxP Services

Strong leadership principles are easy to endorse but far more difficult to apply when stakes are high, timelines are compressed, and decisions carry real consequences. In clinical research, leaders are routinely called upon to navigate protocol deviations, audit findings, cross-functional conflict, and team burnout—often with incomplete information and competing priorities.

Building on the foundational “Four Cs” of leadership—Character, Competence, Caring, and Communication—this session moves beyond theory to explore how these principles show up in real-world, high-pressure situations. Through case-based scenarios, the presenters will examine how effective leaders balance integrity with urgency, empathy with accountability, and clarity with complexity. Attendees will engage in guided decision-making exercises, explore common leadership missteps, and apply practical frameworks to respond to challenging situations with greater confidence and consistency.

Attendees will leave with actionable strategies to strengthen decision-making, foster trust, and lead effectively through the complexity and ambiguity inherent in clinical research environments.

CEU: 1.0 ACRP

Speakers:

• Christina Brennan, MD, MBA, FACRP, Senior Vice President, Clinical Research, Northwell Health

• Elisa Cascade, MBA, FACRP, Chief Growth Officer, TrialScreen

• Christine Senn, PhD, FACRP, CCRC, CPI, SVP, Site-Sponsor Innovation, Advarra

Patient recruitment remains one of clinical research's most persistent bottlenecks: most trials miss enrollment timelines and many sites struggle to identify eligible participants within their own records and communities. Artificial intelligence (AI) is rapidly changing how recruitment is approached, from automated eligibility matching and natural language processing of clinical records to AI-assisted prescreening and outreach. This session offers a practical, vendor-neutral look at where AI can meaningfully support site recruitment and where human judgment remains essential. Attendees will examine the major categories of tools entering the field, learn a framework for evaluating their accuracy, fit, and limitations, and explore the safeguards that responsible adoption demands in terms of informed consent, data privacy, institutional review board oversight, and algorithmic biases. Through real-world scenarios and open discussion, participants will leave with concrete questions to ask and first steps to take when considering AI for their own recruitment efforts.

CEU: 1.0 ACRP

Speaker:

• Rishabh Goel, CEO, Bond Health, Inc.

Clinical trial teams continue to struggle with fragmented processes across sites, sponsors, and contract research organizations. Documents, milestones, and study data often reside in disconnected systems, creating duplication, delays, compliance risks, and increased administrative burden.

This session will explore how organizations could build artificial intelligence (AI)-connected clinical ecosystems through the integration of site and sponsor technologies, including electronic investigator site files, electronic trial master files, and clinical trial management systems. Using real-world implementation examples and lessons learned, attendees will examine practical integration models, governance considerations, and change management strategies that improve collaboration, streamline document exchange, enhance inspection readiness, and reduce operational inefficiencies.

Attendees will leave with actionable approaches to evaluate integration opportunities within their own organizations and strengthen sponsor-site partnerships throughout the study lifecycle.

CEU: 1.0 ACRP

Speaker:

• Guillaume Gerard, Chief Operating Officer, Agatha Inc

The International Council for Harmonization (ICH)  E6(R3) guideline for Good Clinical Practice pushes trial teams to collect less, but more important, data while maintaining a focus on critical-to-quality factors, avoiding unnecessary data fields, and designing collection around the protocol’s real risks and objectives. It also shifts strategy toward risk-based quality management, stronger data governance, and fit-for-purpose digital systems with traceable audit trails. This session will examine how, in practical terms, E6(R3) means data collection planning must start during protocol design, with a clear map of which data are critical and why. For trial teams, earlier input by data management and informatics experts results in quality-driven collection, rather than volume-driven collection, with a clear path to operational success.

CEU: 1.0 ACRP

Speaker:

• Jaime Baldner, Research Informatics Director, University of Arkansas for Medical Sciences