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.