ACRO's Good Clinical Podcast

As clinical trials become increasingly digital and interconnected, cybersecurity is critical to protecting data integrity, maintaining trial continuity, and safeguarding patient safety. In this episode of ACRO’s Good Clinical Podcast, Sophia McLeod is joined by cybersecurity leaders Nelly Nauman (Parexel), Mick Ryan (ICON), and Charley Newberry (Syneos) to explore the evolving cyber threat landscape facing clinical research.

In this episode, they discuss emerging cybersecurity risks, including AI, ransomware, third-party vulnerabilities, and decentralized trials. Speakers shared their experience and strategies for strengthening cyber resilience, protecting data integrity, and fostering industry collaboration to safeguard clinical research.

They also shared perspectives on emerging security challenges and why cybersecurity, data trust, and patient safety must be built into clinical trial design from day one.

Collaboration is at the core of connecting the clinical research ecosystem without adding to the technology burden for sites. The ongoing partnership between Advarra and ICON offers a practical example of what this can look like.

In Good Clinical Podcast Season 5, Episode 3, Mike Eckrote (Advarra) and Travis Caudill (ICON) discuss how their collaboration is helping move toward an ecosystem where organizations and sites can continue using the tools that best meet their needs, while enabling information to flow seamlessly across systems and organizational boundaries.

They explore the potential to reduce administrative complexity, improve interoperability, strengthen site efficiency, and keep humans at the center of critical decisions, ultimately creating more time and capacity for what matters most: patients.

What does the future of early-stage clinical research look like?

In this episode, experts from clinical operations, IRB/regulatory oversight, and technology/policy — Amy Roach (Parexel), Bert Wilkins (WCG), and Jackie Ward (Veeva) — explore the evolving landscape of early-stage clinical trials in the U.S.

From regulatory modernization and global competitiveness to interoperability, participant access, and increasingly complex trial designs, the discussion centers on how the U.S. can improve speed, efficiency, and predictability while preserving safety, rigor, and quality.

AI is transforming trial monitoring from a reactive process into a proactive, risk-driven discipline. In this episode, ACRO RBQM Working Group members Cris McDavid (Parexel), Shailesh Madel (ICON), and Linda Phillips (IQVIA), come together to examine how artificial intelligence and machine learning can help identify risks and signals faster while humans maintain accountability and oversight.

From accelerating the identification of Critical-to-Quality (CtQ) factors and enhancing centralized monitoring to addressing concerns around pushing humans out of the loop, the discussion highlights both the challenges and opportunities ahead. With insights on how AI is already being leveraged to increase operational efficiencies while balancing patient safety and data integrity, this episode offers a glimpse into the future of centralized monitoring.

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.

In this episode, Jonathan Norman (Director, Localisation Services, YPrime) and Laura Russell (Senior Vice President, Head of Data and AI Product Development, Advarra) join the podcast to discuss how artificial intelligence is transforming today’s clinical operations.

They dive deeper into how AI can be used to improve protocol design, drive efficiency in localization processes, and modernize clinical operations to expand access to trials and get treatments to patients sooner.

In the latest collaboration between ACRO and TransCelerate BioPharma, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week’s episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry.

They dive deeper into their experiences implementing the new guidance at their respective companies, the new opportunities that R3 has created in the partnership between CROs and sponsors, and how they envision the future state of R3 once industry has fully embraced the guidance.

FIND ACRO & TRANSCELERATE'S ICH E6(R3) TOOLS & RESOURCES HERE: https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/

Malaikannan Sankarasubbu (Chief Technology & AI Officer, Saama) and Jonathan Shough (Chief Information Officer, Parexel) join this week’s episode to discuss how the strategic use of AI technologies is transforming clinical development.

They dive deeper into which advancements in generative AI have the potential to improve the clinical trial workflow, the integration of AI and predictive analytics in risk assessment processes, and the importance of strong change management strategies when implementing new AI technologies.

On this episode, Tania Simoncelli (Vice President, Translational Impact and Engagement, Chan Zuckerberg Initiative) and Nasha Fitter (Co-founder & CBO, Citizen Health and Co-founder & CEO, FOXG1 Research Foundation) join forces to discuss how rare disease patient advocacy has transformed over time and how the biopharmaceutical industry should adapt to better meet the needs of today’s patients.

They dive deeper into the evolution of rare disease patient advocacy groups, why industry must move beyond the hyperfocus on “blockbuster drugs” to make progress in rare disease research, and how advancements in rare disease treatments can benefit the clinical research ecosystem for all.

What does clinical trial monitoring have in common with growing a field of corn? Amy Kroeplin (PPD™ clinical research business of Thermo Fisher Scientific), Shailesh Madel (ICON plc), and Nicole Stansbury (Premier Research) join the podcast to discuss the importance of risk-based quality management, centralized monitoring, and strategic SDV/SDR sampling strategies.

They dive deeper into the unique roles of SDV and SDR, different methods of implementing SDV/SDR sampling strategies, and the industry imperative to increase centralized monitoring adoption.

On this week’s episode, Lisa Moneymaker (SVP, Head of Strategic Customer Engagement, Medidata Solutions) and Adam Aten (Legislative & Regulatory Policy Lead, Verily) join the podcast to discuss how the clinical research industry must use insights from the past to better prepare our AI models and other technologies to meet the needs of patients in the present and future.

They dive deeper into the role that collaboration between technologists and clinical scientists can play in helping to reduce bias in our AI models, what legislators and regulators should be keeping top of mind as they write new rules of the road for AI and ML, and ACRO’s ongoing efforts to promote the responsible use of AI in clinical research.