In this episode of ACRO's GCP, Tinaya Gray (Executive Director, Site Engagement & PACE at ICON plc), Jan Hewett (SVP, FDA Regulatory Advisor at Advarra), and Jackie Kent (Independent Advisor) unpack the work of ACRO's dive team on representative, generalizable clinical trial data at the 2025 Innovation Network Gathering. Together, they explore why clinical trial populations still fail to reflect real-world patients, and what's been holding the industry back from meaningful progress.

The conversation goes beyond identifying the problem. The group shares how a diverse set of stakeholders were able to align around practical, implementable solutions. They also discuss how industry can pilot new approaches, engage broader stakeholders, and turn promising ideas into standard practice. This episode offers a candid and solutions-oriented look at how to generate clinical data that truly supports better decision-making for all patients.

Artificial intelligence is reshaping clinical research, but its impact extends far beyond automation. In this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Paulo Limgenco (VP, Business Operations at YPrime) and Michael Tucker (VP, Patient Experience - Commercial at Medidata) to explore how AI and digital technologies are helping the industry build more sustainable, efficient, and patient-centered clinical trials.

From protocol optimization and site selection to localization and decentralized trial models, the conversation examines how AI can reduce operational burdens, minimize waste, and expand access to research opportunities for underrepresented populations. The discussion also highlights the importance of responsible AI adoption, including strong governance frameworks, data stewardship, and human oversight.

Tune in for an insightful conversation on how the industry is balancing innovation and responsibility while working toward a future where clinical trials are more efficient, inclusive, and sustainable for patients, sites, sponsors, and communities worldwide.

What does it take to run successful clinical trials across borders? Tune in as Chris Boone (Group VP, Research, Health & Life Sciences at Oracle) and Alicia Baker McDowell (VP & Head of Global Regulatory Strategy at Fortrea) explore the shift from transactional outsourcing to truly co-created partnerships.

They discuss how sponsors, CROs, and tech partners are redefining collaboration, tackling data fragmentation, and striking the right balance between global consistency and local execution to deliver more effective clinical trials worldwide.

Artificial intelligence is rapidly reshaping the landscape of rare disease research -- but how close are we to realizing its full potential? In this episode, Tanya Binette (Director of Therapeutic Expertise, Rare Disease at ICON plc) and Roz Round (SVP of Operational Strategy, Patient and Site Engagement at Precision for Medicine) explore how AI is being applied across the rare disease clinical trial lifecycle, from drug discovery and protocol design to patient identification and engagement.

The discussion highlights both the promise and complexity of using AI in a research space defined by small patient populations, fragmented data, and unique ethical considerations. Guests emphasize the importance of patient trust, regulatory alignment, and responsible innovation, while also identifying opportunities to accelerate trials, improve access, and empower patients through AI-enabled tools.

Site feasibility remains a critical yet complex component of clinical trial startup. In this episode, listen as Andrea Bastek (VP, Market Strategy at Florence Healthcare), Christine Senn (SVP, Site-Sponsor Innovation at Advarra), and Ashley Davidson (SVP, Head of Product at Advarra) unpack the persistent challenges in feasibility -- from manual, time-intensive processes and data trust gaps to misaligned timelines and limited transparency between stakeholders.

The conversation explores how collaboration, smarter process design, and emerging technologies like AI and real-time data integration can reduce burden on sites and improve study startup timelines. Guests also share practical recommendations, including simplifying CDA processes, improving communication between sponsors and sites, and leveraging data more effectively to move forward toward a more efficient and connected feasibility model.

Resources:

- Advarra CDA Template
- Advarra Site ID Feasibility Solution
- Paper from Florence Healthcare's Site Enablement League

What does "patient-centricity" actually look like in practice, and why does it still fall short? In this episode, Stacy Hurt (Chief Patient Officer at Parexel) and Alicia Staley (Chief Patient Officer at Medidata) bring both lived experience and industry insight to a powerful discussion on the gaps between intention and reality in clinical research. They unpack the emotional and logistical challenges patients face, from navigating fragmented systems to feeling dismissed by well-meaning but unhelpful messaging. The discussion highlights the need for systemic thinking, stronger partnerships with advocacy communities, and greater adoption of patient leadership roles. With real-world examples and a forward-looking perspective, this episode offers a roadmap for turning patient-centricity into tangible change.

What happens when clinical trial sites are given the resources and autonomy to determine precisely what their site needs to be successful? In this episode, participants from the ACRO Site Grants Program share how targeted funding helped them tackle real-world barriers to clinical trial access and diversity. 

From community-based outreach and patient education, to internal infrastructure and staffing, these sites implemented tailored solutions designed to meet the unique needs of their communities. Along the way, they encountered challenges, adapted their approaches, and uncovered valuable lessons about trust-building, flexibility, and long-term engagement.

This conversation highlights how even small investments can drive meaningful change at the site level, and what the broader industry can learn from these experiences.

Artificial intelligence is reshaping every stage of drug development, but unlocking its full potential requires more than technology alone. In this episode, Clay Alspach (Executive Director, ACRO) Raja Shankar (VP of Machine Learning at IQVIA), and Andrew Mackinnon (SVP & Executive General Manager at Medable) come together to examine how policy, regulation, and global collaboration will shape the future of AI in clinical trials.

From breaking down data silos to addressing regulatory uncertainty and enabling a “try first” mindset, the discussion highlights both the opportunities and the complexities ahead. With insights on patient impact, site experience, and the next wave of innovation, this episode offers a roadmap for advancing AI in a way that is both responsible and transformative. 

LINK TO ACRO'S RBQM SUMMARY REPORT: https://www.acrohealth.org/rbqm-summary-report/

In this episode, ACRO RBQM Working Group members Lauren Garson (Veeva), Cris McDavid (Parexel), and Jennifer Stewart (Premier Research) joined ACRO’s Good Clinical Podcast to discuss key takeaways from ACRO's annual RBM/RBQM Landscape Survey. Since 2019, ACRO's RBQM survey has dug into trial-level data on industry adoption of RBM and RBQM components. Informed by conversations with FDA, the aim of the survey is to evaluate ACRO member companies’ adoption of risk-based monitoring to better understand how the larger framework of risk-based quality management (RBQM) are being adopted across the clinical trial industry.  

In 2024, ACRO announced its D&I Site Resource Grants Program. Designed to support an innovative 12-month pilot project, the site resource grants act as a platform to incubate innovative strategies for improving representative enrollment in clinical research.  On this episode, site grantee representatives Dr. Ammara Mushtaq, MD (Brooklyn Clinical Research), Dr. Lovie Negrin, APRN (Randomize Now), and Sandra Carmona Torres, BSN (K2 Medical Research) join the podcast to discuss the lessons learned through implementing their pilot projects so far. They dive deeper into how sites can address barriers to participation, the need for consistent investment in building trust and engaging local community members, and the state of clinical research from a site perspective.