WCG Talks Trials

Study start-up remains one of the most persistent bottlenecks in clinical trials—slowing site activation, delaying patient enrollment, and adding pressure across already stretched teams. In this episode of WCG Talks Trials , host Jamie Harper, Vice President of Site Solutions & Engagement at WCG, is joined by Stephanie Held, Associate Director of Coverage Analysis, and Jody Ingebritsen‑Howe, Director of Contracts & Budgets, to unpack why start-up timelines continue to stall and what can be done to improve them. Together, they explore how Medicare Coverage Analysis (MCA) serves as the foundation for compliant and efficient study start-up, how downstream processes like budgeting, contract negotiations, and CTMS build are impacted by early decisions, and where “hidden” white space can quietly derail timelines. The conversation also highlights practical, actionable steps sites and sponsors can take today—from mapping end‑to‑end workflows to better equipping negotiators with the information they need. Looking ahead, the panel discusses how technology and AI may reshape study activation, while emphasizing the importance of human expertise and alignment across teams. Whether you’re a site, sponsor, or CRO, this episode offers timely insights to help accelerate activation and reduce friction in an increasingly complex trial landscape. Host: Jamie Harper, vice president, Site Solutions & Engagement Guests: Stephanie Held, associate director, Coverage Analysis Jody Ingebritsen-Howe, director, Contracts & Budgets

Clinical trial complexity is rising with more procedures, endpoints, and technology, yet sites are turning these pressures into pathways for improvement. In this episode of WCG Talks Trials, host Jenna Goeller sits down with Trevor Cole to unpack practical ways research sites sustain readiness, build resilience, and spark innovation amid frequent protocol amendments and technology overload. Together, they explore what’s changing on the ground and how sites are responding with stronger feasibility reviews, capacity planning, streamlined protocol advocacy, and risk‑proportionate oversight – all grounded in Quality by Design and the updated ICH E6(R3) guidance. Listeners will hear data‑driven insights on: The operational ripple effects of complexity, including resource strain, rework from amendments, and tech support burdens, and what’s working to reduce them. Day‑to‑day applications of risk‑based quality management, data governance, and proportionality to protect participant safety and data integrity. Culture and maturity for empowering teams, mapping processes before SOPs, continuous training, Correction and Preventive Action (CAPA) discipline, and knowledge sharing across silos. How sponsors and CROs can better support sites through integrated technology, protocol simplification, early collaboration, and transparent communications. Turning complexity into growth by investing in people and processes, using fit‑for‑purpose tech (including selective AI use), and engaging local communities. Speakers: Jenna Goeller, Associate Director, Clinical Trial Insights & Analytics, WCG Trevor Cole, Program Director, Clinical Solutions & Partnering, WCG

In this episode of WCG Talks Trials , host Gabriella Tost sits down with Latin America regional experts Mercedes Lopez, Camila Santos, and Sebastian Florez to explore how artificial intelligence, telemedicine, and wearable technologies are reshaping clinical research across Latin America. From expanding access through virtual care to empowering patients with biosensors, the conversation highlights how digital tools are breaking longstanding barriers to participation — especially for rural and underserved communities. The group dives into the growing role of AI in participant identification, site selection, and overcoming fragmented health records — challenges historically unique to the region. They also discuss rapid regulatory modernization in countries like Brazil, Mexico, and Ecuador, which is accelerating approvals, enabling decentralized trials, and fostering a fertile environment for global investment. Looking ahead, the experts paint an exciting picture of what research will look like by 2026: connected data ecosystems, hybrid study models, stronger community engagement, and more inclusive recruitment than ever before. Whether you're a sponsor, site, or technology innovator, this episode offers clear insights into why Latin America is becoming a global leader in digital-forward, participant-centered clinical trials. For more into these insights, read their article, “AI and the Digital Future of Health in Latin America: A Sponsor's Opportunity,” in the 2026 Trends & Insights Report .

In this episode of WCG Talks Trials, Sandy Smith, Sylvia Baedorf Kassis, and Dr. Donna Snyder discuss the critical role of health literacy in clinical research. They explore how clear communication can enhance patient understanding and engagement, the importance of a common language in research, and the introduction of the MRCT Center’s Clinical Research Glossary as a tool to facilitate better communication. The conversation emphasizes the need for consistent terminology and the integration of health literacy practices in clinical research to improve participant experiences and outcomes. Key highlights: Health literacy is crucial for effective communication and participant engagement in clinical research. The MRCT Center’s Clinical Research Glossary helps simplify complex terms into plain language, supporting understanding for all stakeholders. Consistent terminology and clear communication empower participants, improve data accuracy, and enhance patient advocacy. Integrating health literacy practices leads to better retention and experiences for trial participants. Host: Sandy Smith, RN, MSN, AOCN, senior vice president, clinical solutions & strategic partnering, WCG Guests: Sylvia Baedorf Kassis, MPH, program director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard Donna Snyder, MD, MBE, executive physician, WCG

In this episode of WCG Talks Trials, Cristin MacDonald, Doug Mayer, and Tyler Bye discuss how Software as a Service (SaaS) solutions are democratizing the clinical trial landscape. Learn how SaaS platforms are enabling organizations of all sizes to leverage cutting-edge technology, improving collaboration, standardization, and data security throughout the clinical research process. The team shares the benefits of adopting SaaS, practical insights for successful implementation, and highlights the pivotal role of technology partnerships in supporting innovation and research efficiency. Tune in to discover how your organization can optimize clinical trials and accelerate research impact with SaaS technology.

In this episode of WCG Talks Trials, Silvio Galea, chief data and analytics officer, and Bryan Wayne, vice president of imaging operations, both of WCG, explore the critical role of imaging in clinical trials. Together, they break down industry acronyms, unpack the process of independent image review, and discuss how WCG is contributing to the validation and implementation of AI-driven radiology solutions. Listen in as they share behind-the-scenes insights into core lab operations, the significance of sample size and study design, and how emerging technology is shaping the future of clinical research. Whether you are a clinical trial professional, healthcare innovator, or simply curious about the intersection of AI and research, this episode provides valuable perspectives on driving efficiency, accuracy, and better outcomes in clinical research imaging. For more information about WCG’s imaging solutions, visit wcgclinical.com/imaging .

In this episode of WCG Talks Trials, Sandy Smith, senior vice president, clinical solutions & strategic partnering, WCG, is joined by Tiffany Pierce, director, clinical trials core, Henry Ford Health System, to discuss resilience in clinical research. As the landscape of clinical trials faces evolving challenges, they explore how organizations and institutions, like Henry Ford Health, are addressing disruptions, uncertainties, and changes at the federal level. Learn about innovative strategies to enhance trial efficiency, including role clarity, flexible workflows, and diversifying research portfolios. With a focus on maintaining forward momentum in trials and remaining nimble, they discuss actionable solutions to administrative burdens and enhance the efficiency and speed of trial completion. This episode offers invaluable guidance for professionals seeking to stay agile and adapt to ongoing changes in the clinical trials. HOST: Sandy Smith SPEAKER: Tiffany Pearce

Dive into the world of generative AI with Silvio Galea, chief data analytics officer, WCG, and Kyle Miller, lead data scientist, WCG. In this compelling episode of WCG Talks Trials, we explore how Generative AI can improve clinical research workflows from meticulous data entry to efficient data validation. Uncover the technology behind AI’s ability to assist in document updates, highlight transcription biases, and digitize complex data for predictive analytics. Understand the importance of human oversight and practical applications that can optimize how clinical trials are conducted. Whether you’re curious about AI’s role in reading dense documents or leveraging pipelines for innovation, this episode provides the insights you need. Guests: Silvio Galea, chief data and analytics officer, WCG Kyle Miller, lead data scientist, WCG

In this episode of WCG Talks Trials, join Silvio Galea, chief data and analytics officer, WCG, and Melissa Hutchens, vice president of research and benchmarking, WCG, as they discuss the transformative role of AI in clinical trials. Discover how generative AI and other AI technologies are enhancing the quality of clinical trials, reducing cycle times, and cutting costs. The episode covers the benefits, barriers, and concerns associated with AI, and explores its applications in drug discovery, participant recruitment, trial design, and more. Tune in to learn about the latest advancements in AI and how they are shaping the future of clinical trials. Guests: Silvio Galea, chief data and analytics officer, WCG Melissa Hutchens, vice president of research and benchmarking, WCG

Join us for "Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials" as we uncover the complexities of site management and the barriers to effective study start-ups. Discover the top issues impacting research sites and strategies to overcome them, including trial complexity, start-up hurdles, and long initiation timelines. Learn how effective communication, teamwork, and clear processes can drive success, and the importance of human connections and inclusivity in clinical research. Get practical advice for improving site readiness and trial efficiency from our expert guests. Don't miss this essential episode on navigating the evolving clinical trial landscape at sites. Guests: Jessica Thurmond, program director, WCG Pat Harrington, senior vice president, Clinical Solutions & Strategic Partnering, WCG Brad Gruener, vice president, Site Services, WCG

Join us for a compelling episode of WCG Talks Trials where we take a look into the rewarding world of clinical trials and clinical development. In this episode, George Cokenakes, director of clinical services, review solutions, WCG, speaks with Dr. James Januzzi, a renowned cardiologist at Massachusetts General Hospital, and chief scientific officer at Baim Institute for Clinical Research. Dr. Januzzi shares his inspiring journey, highlighting the significance of clinical trial participation and the diverse opportunities that can shape a medical career. Learn from Dr. Januzzi's extensive experience in clinical research, including his work on cardiac biomarkers, drug therapy development, and involvement in various therapeutic areas. Discover how career decisions and active engagement in clinical trials can open doors to numerous possibilities and significantly impact patient care. Tune in for this insightful conversation and gain valuable advice for budding clinicians and researchers. Speakers: George Cokenakes, PMP, director of clinical services, review solutions, WCG James Januzzi, MD, FACC, cardiologist, Massachusetts General Hospital and chief scientific officer, Baim Institute for Clinical Research

In this episode of "WCG Talks Trials," host Geoffrey Schick, director of strategic site partnerships, WCG, is joined by fellow MAGI@home 2024 speakers Sandy Smith, Jess Thompson, and Wesley Warren. They share their unique perspectives and key takeaways from this year's virtual conference, including discussions on contract negotiations, the evolving role of advanced practice practitioners, and the collaborative panels featuring both site and sponsor/CRO insights. The episode also recaps the impactful session on the FDA's Diversity Action Plan and what it means for the future of clinical trials. Tune in to hear about the dynamic energy, valuable connections, and innovative challenges that make MAGI and MAGI@home standout events in clinical research. Don't miss out on the exciting plans for MAGI 2025 in Boston, where trends will continue to evolve and new opportunities will emerge. Guests: Geoffrey Schick, MBA, CHRC, Director of Strategic Site Partnerships, WCG Sandy Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG Jess Thompson, MS, MBA, PMP, Founder, ACRPM.org Wesley Warren, J.D., Executive Director, Research Strategy & Partnerships, City of Hope

In this episode of WCG Talks Trials, host Sandy Smith, senior vice president of clinical solutions and strategic partnering at WCG, dives into the highlights of the Florence Healthcare Research Revolution event. Sandy is joined by industry experts Andrea Bastek, vice president of innovation at Florence, and Lauren Sobocinski, senior vice president of strategic alliances at WCG, to discuss transformative insights from the event. Discover the latest trends shaping clinical research, including site engagement, protocol complexity, and effective sponsor-site relationships. Tune in for a compelling discussion on how collaborative efforts and innovative technologies are driving positive change in the clinical trial landscape.

In this episode of WCG Talks Trials , host Kelly FitzGerald sits down with Dr. Currien MacDonald, Medical Chair Director at WCG, and Sara Reed, a participant in two psychedelic clinical trials, to explore the evolving landscape of psychedelics research. Dr. MacDonald shares his expertise on the growing acceptance of psychedelics in clinical settings, recent FDA updates, and the inner workings of ongoing trials. Later, Sara provides a firsthand account of her experiences as a trial participant, offering unique insights into how psychedelics are being tested as potential therapeutic options. Tune in to learn more about aligning clinical practice with patient experience in this emerging field.

In this episode of WCG Talks Trials, Geoff Schick, director of strategic site partnerships, joins our host Sandy Smith, senior vice president of clinical solutions and strategic partnering, to discuss the expansion of research site cancer portfolios.

Join Desiree Underwood-Williams, director of project management organization at WCG and guest Steve Smith, CEO of SteveSmithPlans LLC and facilitator of the WCG Patient Forum , as they recap the latest Patient Forum Focus Session on breakthrough science and community engagement. Discussion highlights include: The impact of medical diagnoses on families with Sickle cell disease and melanoma. New research in cell and gene therapy that’s directly impacting Sickle cell disease and melanoma patients. New diversity laws shaping the future of drug development. Community engagement and how patients can get involved in their care. And more insights into the WCG Patient Forum, now in its fifth year. Tune in to learn more about clinical research, community engagement, and the latest developments in patient care.

In this episode of WCG Talks Trials, we are joined by host Joanne Thomas, clinical reviewer and patient advocate at WCG, along with our guest Currien MacDonald, medical chair director at WCG. This episode covers the roles of IRB in ethical clinical research, frequently asked questions, and a general overview of the IRB’s role in clinical trials.

This episode of WCG Talks Trials addresses site feasibility challenges impacting the clinical trials industry. Join Michelle Yu, associate director of clinical strategy at WCG, and our guest Trevor Cole, director of client delivery, site and strategic operations for WCG, as we discuss approaches to adopt innovative feasibility and site start-up solutions. Here are links to documents referenced in this episode: Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement Main Article: https://ascopubs.org/doi/10.1200/OP.20.00821 PDF Data Supplement: https://society.asco.org/sites/new-www.asco.org/files/content-files/about-asco/documents/2020-ASCO-Site-Feasibility-Assessment-Statement-Data-Supplement-for-JCO-OP.pdf

Join our Chief Analytics Officer Silvio Galea, along with Dr. Donna Snyder & Dr. Barbara Bierer to discuss opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The discussion is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and WCG will address the growing need for guidance in this rapidly evolving area of research.

In this episode of WCG Talks Trials, we are joined by WCG clinical science experts as they discuss traditional measurement challenges for PTSD trials and how the use of an electronic CAPS-5 scale is improving administration and scoring errors. Tune in as we discuss the CAPS-5 scale, the opportunities and benefits of using an electronic version to help standardize scale administration and scoring across clinical research, and the promising results to date.