Driving Innovation and Patient-Centricity in Clinical Trials – Highlights from SCOPE Summit 2025
Key Takeaways from SCOPE Summit 2025
Patient-Centricity is Non-Negotiable: Trials must prioritize patient needs, reduce burdens, and improve engagement to succeed.
AI and Digital Health are Game-Changers: From protocol design to patient matching, AI is transforming every aspect of clinical trials.
Diversity and Inclusion Drive Better Science: Equitable representation in trials is essential for developing treatments that work for all populations.
Decentralized Trials are Here to Stay: Remote monitoring and virtual visits are key to improving access and retention.
The Future is Integrated: The convergence of clinical research and healthcare delivery will redefine how trials are conducted.
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The 16th annual Summit for Clinical Operations Executives (SCOPE) 2025 brought together over 4000 clinical research professionals, thought leaders, and innovators from 1,200+ organizations to explore the latest challenges and opportunities shaping the future of clinical trials. TrialX was proud to participate in this year’s event, with our Chief Strategy Officer (CSO), Paul Donnelly, and Senior Director of Client Services, Wes Martz, representing the company as a leading innovator in healthcare technology. Paul and Wes engaged with industry leaders, shared insights, and discussed how TrialX’s cutting-edge solutions are revolutionizing the clinical trial landscape.
Patient-Centricity Takes Center Stage
Patient-centricity remained a dominant theme at SCOPE 2025, with sessions emphasizing the need to prioritize patient needs, improve engagement, and reduce barriers to participation. The opening keynote panel, “What Do Real Patients Actually Talk About?”, underscored the importance of authentic patient representation and inclusive narratives in clinical research.
Panelists like Quynh Tran (Cystic Fibrosis Foundation) and Dr. Fabian Sandoval (Emerson Clinical Research Institute) highlighted the need for honest communication and social listening to understand patient challenges. Paul Donnelly, TrialX’s CSO, echoes this sentiment, noting that “Putting the patient first in the planning process eliminates the vendor-only approach.” This focus on patient-centricity is not just a trend but a necessity for improving recruitment and retention in clinical trials. At TrialX, we’ve long championed patient-centric approaches. Our AI-powered Patient Recruitment Management System simplifies and accelerates clinical trial enrollment by leveraging advanced matching algorithms, multi-channel outreach, and real-time tracking. This ensures that the right patients find the right trials—efficiently and effectively.
AI and Digital Health: Transforming Trial Execution
Artificial intelligence (AI) and digital health technologies were trending topics at SCOPE 2025, with discussions highlighting their potential to streamline trial design, enhance data collection, and improve patient outcomes. The panel on “Balancing Innovation Options to Enable Adoption” explored how sponsors and sites can integrate new technologies without overburdening workflows.
Speakers like Jean Kelly (Rochester Clinical Research) and Teri Wright (Eli Lilly) emphasized the importance of collaboration between sponsors, sites, and technology providers. TrialX’s Remote Data Collection Platform aligns with this trend, enabling real-world data capture for clinical research studies—on Earth and even in space! By integrating various wearables and devices, it ensures seamless, real-time insights while enhancing patient engagement.
With sponsors investing heavily in AI-driven technologies, the industry is projected to make a $22 billion investment over the next few years. However, Paul cautions that “It’s still early to determine where exactly the value will be.” Recruitment prediction is a key area where AI is making an impact—“If you’re not using AI for recruitment, it’s table stakes.” But, as Paul emphasized, “You can’t bypass the patient.” Building trust and ensuring ethical AI use are critical for long-term success.
Diversity, Equity, and Inclusion in Clinical Trials
Diversity and inclusion were key focus areas at SCOPE 2025, with panels exploring strategies to improve representation in clinical trials. The session on “Advancing Clinical Research Through Strategic Partnerships: The SGM Alliance SOGI Business Case” highlighted the ethical and scientific imperative of including sexual and gender minorities (SGM) in research.
Panelists like Craig Davenport (Eli Lilly) and Lisa Moneymaker (Medidata) discussed how inclusive trial design and comprehensive data collection are critical for developing therapies that benefit all patients. TrialX’s patient recruitment management solution is designed to facilitate diversity and inclusion by enabling granular patient outreach and creating tailored experiences for underrepresented communities. For example, the Let’s Win Pancreatic Cancer Clinical Trial Finder, powered by TrialX, helps patients and caregivers find relevant clinical trials with AI-guided search, bilingual support, and personalized trial matching.
Wes notes “It’s no longer about decentralized clinical trials; it’s just clinical trials.” Sponsors are pivoting by trying new site and trial models, with hybrid and fully virtual trials becoming the standard. This shift is a fundamental change in how trials are conducted.
Decentralized Trials and Remote Monitoring
Decentralized clinical trials (DCTs) and remote monitoring technologies continue to gain traction, with sessions exploring their potential to improve patient access and retention. Discussions emphasized how these innovations enable sponsors to conduct studies more efficiently while reducing the burden on patients and sites.
Our Remote Data Collection Platform supports virtual visits, real-time communication, and seamless integration with wearables and devices. This ensures a smooth trial experience for patients while providing sponsors with actionable insights. By integrating these technologies, TrialX is helping sponsors accelerate trial timelines and improve patient retention rates.
Regulatory Insights and Modernization Efforts
Regulatory updates were also a key focus at SCOPE 2025, with significant discussions on how evolving FDA guidelines are shaping the future of clinical trials. A standout session was the keynote panel titled “Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There”, featuring Dr. Mark McClellan, former FDA Commissioner and current Director of the Duke-Margolis Institute for Health Policy, alongside Janice Chang, CEO of TransCelerate Biopharma Inc.
Dr. McClellan shared valuable insights on the future of clinical research, emphasizing the need for a healthcare system that seamlessly integrates research into routine care. He discussed how digital advancements and AI-driven tools could enhance trial efficiency and patient participation. These advancements align with the FDA’s Guidance on Decentralized Clinical Trials, which provides a framework for sponsors to implement remote monitoring, telemedicine, and digital tools while maintaining compliance.
Janice Chang echoed these sentiments, stressing the importance of simplifying protocol design and enhancing data interoperability to improve patient accessibility and trial efficiency. Together, they painted a compelling vision for the future, where clinical research and healthcare delivery are seamlessly integrated.
Interoperability and data standards were recurring themes at the summit. “The industry needs to limit fragmentation and become increasingly more cooperative,” Paul suggests. There’s a growing demand for streamlined data and workflows without sacrificing quality, as “Quality is an enabler of good clinical trials.” Andy Lee from Merck summed it up well: “Cost is what you give, value is what you get.”
Spotlight on Patient-Centric Recruitment and Retention
Several sessions at SCOPE Summit 2025 highlighted innovative strategies for improving patient recruitment, retention, and site efficiency. One standout presentation was led by Whitley Albright, Clinical Innovation and Operations Strategy Lead at Sanofi, who shared insights on scaling patient-centric recruitment in global asthma programs.
Albright discussed how Sanofi is keeping patients at the center of focus while reducing site burden through targeted outreach, live medical secondary screening, and centralized patient recruitment management. By pre-qualifying patients and maintaining a program-level rematching system, Sanofi has improved referral-to-consent ratios and ensured that disqualified patients remain engaged for future trials. These efforts align with TrialX’s mission to simplify patient recruitment and enhance site efficiency through our AI-powered Patient Recruitment Management System.
Another compelling session featured Sara Pierson and Melinda Rottas from Pfizer Inc., who emphasized the importance of creating a seamless participant experience in clinical trials. Their presentation, “Patients, Connection, Clinical Trials,” highlighted Pfizer’s commitment to ensuring that participants remain connected to research from initial information-seeking through study closure and beyond. Pfizer’s focus on participant ecosystems and long-term engagement resonates with TrialX’s approach to patient-centric trial design.
Looking Ahead
As we reflect on the SCOPE Summit 2025, we’re inspired by the progress being made in the clinical research industry and energized by the opportunities ahead. Collaborative efforts drive impactful change, and governance is the key to keeping objectives moving in the right direction. All partners in the Sponsor-CRO-Vendor ecosystem bring an important skill to the triple threat. Sponsors bring therapeutic area expertise, CROs provide clinical operation resources, and tech providers cover the tech, data capture, and participant/site experience. This collaborative approach is essential for driving innovation and improving trial outcomes.
TrialX remains committed to driving innovation, fostering collaboration, and advancing patient-centric solutions that transform the clinical trial landscape. We’re excited to continue this journey and look forward to sharing more updates on how TrialX is shaping the future of clinical trials. For more information about our solutions, visit www.trialx.com.
