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