In my role at TriNetX, I have the privilege of engaging with leaders across the clinical research landscape who are challenging the status quo and pushing us toward a more inclusive, tech-enabled, and patient-first future. One of the most rewarding conversations I’ve had recently was with two such leaders: Cindy Markham and Courtney Roshau from Ora, a global ophthalmology-focused contract research organization (CRO).
Cindy and Courtney joined me for an episode of our vodcast series, The Future Prescription: Inside the Trends. The theme of our discussion? “Care Reimagined: Patient-Centricity from Trials to Treatments.” But this wasn’t just a surface-level take on a buzzword. This was a deep dive into how patient centricity is fundamentally transforming the clinical research paradigm and what it will take to get it right.
Here are a few of the most powerful insights we uncovered. For the full conversation, I encourage you to watch the episode.
The Human Why Behind the Research
We began the conversation by grounding ourselves in the “why.” Cindy, Chief Commercial Officer at Ora, shared a deeply personal story about her father benefitting from a therapy she helped bring to market, an experience that crystallized the impact of our work in this industry. For Courtney, Vice President of Operations Posterior Segment at Ora, it’s the lived experience of the patients she’s supported across years of managing complex eye disease trials that informs every operational decision she makes.
This dual perspective, personal and professional, set the tone for the entire discussion. Patient centricity, after all, isn’t a strategy; it’s a mindset.
Trial Access Is Still the Front Line
One of the first challenges we tackled was trial access. The rise of decentralized trials and remote monitoring has opened new doors, but technology alone won’t solve the access problem. Cindy reminded us that meaningful access requires meeting patients earlier in their disease journey, leveraging real-world data (RWD), and using tools like artificial intelligence (AI) to identify candidates faster and intervene sooner.
Courtney expanded on this, especially in the context of patients with vision or mobility challenges. She stressed how even the smallest operational choices, like offering pre-arranged transportation or simplifying consent forms, can dramatically reduce barriers and increase retention. When trial participation feels like a burden, patients opt out. It’s that simple, and that fixable.
Technology Must Be in Service of the Patient
We also explored how wearables, digital health tools, and AI are being applied to reduce friction for both patients and sites. At Ora, Courtney described how they’re using AI to scan electronic health records (EHRs) and multimodal imaging to better match patients with studies before those patients even walk into the clinic. Not only does this reduce screen failures, but it also spares patients from the disappointment of learning they don’t qualify after investing time and energy.
These kinds of innovations are reshaping how we think about trial efficiency. But as Courtney noted, they must be deployed with balance. Overloading patients with devices and digital tasks in the name of innovation can backfire. Sometimes, less truly is more.
Redefining Endpoints with Empathy
Another critical area we examined was the evolution of clinical endpoints. As more trials aim to intervene earlier in disease progression, traditional markers like visual acuity in ophthalmology may no longer capture what’s most meaningful to patients.
Cindy and Courtney gave fantastic examples of new tools being developed to address this gap, like Ora’s Visual Navigation Course (VNC™) and their EyeCup™ technology, which allows patients to take eye images at home between visits. These are not just more convenient solutions; they reflect a broader shift toward measuring what matters to patients in their everyday lives.
This, in turn, is sparking more collaborative engagement with regulators around what constitutes a meaningful outcome. The industry is no longer asking if patient-reported outcomes matter; we’re asking how to design and validate them rigorously.
Building with (and Not Just for) Patients
Perhaps the most thought-provoking part of our conversation was around empathy in trial design. Courtney spoke passionately about the importance of truly engaging with patients early; not making assumptions about their needs but actually involving them in the design of consent forms, protocols, and data collection tools.
Ora has gone so far as to establish patient panels and co-develop documents with individuals affected by retinal diseases. This level of partnership changes everything, from compliance to long-term retention, and sends a powerful message that patients are not just study subjects. They are collaborators in the pursuit of better science.
The Culture and Commerce of Centricity
As Chief Commercial Officers, Cindy and I also discussed the strategic dimension of patient centricity. She made a compelling case that prioritizing patient needs is not only ethically imperative but commercially advantageous. When you reduce burden, improve access, and align trial protocols with real-world experience, you accelerate timelines and improve data quality. That’s value creation in every sense of the term.
We’re also seeing new expectations from sponsors who want earlier scientific collaboration, especially around endpoints and regulatory strategy. True differentiation now comes from being able to partner not just operationally, but strategically, scientifically, and empathetically.
What’s Next in Patient-Centric Trials
When I asked Courtney and Cindy what they see on the horizon, their answers were as exciting as they were pragmatic. Expect more use of AI to predict disease progression, more data sharing across primary care and specialty providers, and more home-based assessments that connect trials to daily life.
But beyond the tools and technologies, they emphasized the need for creativity. As Cindy put it, we’re at an inflection point. The companies that will lead the next era of research are the ones willing to reimagine every piece of the trial experience—from access and design to communication and culture.
Want more? This blog is only a snapshot of a rich, dynamic conversation about the future of clinical research. To hear more about how Ora is putting patients first and how we can all design better, smarter, more empathetic trials, I invite you to watch the full episode of Care Reimagined: A Patient-Centric Future for Clinical Trials.
Watch now and explore the full Future Prescription report for an in-depth look at the five trends shaping healthcare and clinical research.
About Shields Carstarphen
Prior to TriNetX, Shields Carstarphen invested 16 years of her career with PPD, a part of Thermo Fisher Scientific, and was most recently Senior Vice President of Commercial. Her leadership has been recognized for excellence both in sales and management performance. Shields’ career began in business development at Rho, Medifacts International, and TIBCO Software. She earned her bachelor’s degree at the University of North Carolina at Chapel Hill.
About Cindy Markham
Cindy has more than 25 years of leadership experience in public and private full-service CROs where she has led the global expansion of Phase II-IV business. She brings a deep understanding of customer challenges in drug development and is known for driving transformation. She is passionate about serving customers and creating high-performing teams that do the same. Prior to Ora, Cindy served as Chief Commercial Officer for LabConnect, a global central lab as well as SVP, Commercial for PPD, a large, global CRO.
About Courtney Roshau
With 15 years of clinical operations experience exclusively in ophthalmology, Courtney is responsible for global operations, quality standards, and process optimization across Ora trials for Retina, Glaucoma, and other complex eye diseases. Her experience spans the globe, from first-in-human to pivotal programs including rare diseases and gene therapy trials, across the USA, Europe, LATAM, and APAC. Known for developing close site partnerships and building strategies to find challenging patient profiles for rare disease, Courtney is an innovator who frequently partners with pharmaceutical clients on new tools and screening methods to deliver clinical success.