By Barbara Lopez Kunz, CEO, Caidya
I had the privilege of delivering a keynote presentation at the Florence Healthcare Research Revolution Summit recently, where I shared a vision for transforming the way our industry approaches clinical research. Biopharma, biotech, and pharma leaders know well the challenges we face: escalating costs, lengthening timelines, inefficiencies, and a persistent gap between the needs of patients and the realities of clinical trials. My presentation, drawn from my experience across R&D and global healthcare, focused on why we cannot continue with incremental fixes. Instead, we must embrace a new paradigm—one that is holistic, patient-first, agile, and collaborative.
The Current Clinical Development Landscape
The data speaks for itself. Bringing a new drug to market costs, on average, $2.3 to $2.6 billion, with timelines stretching 12 to 15 years. Despite decades of effort, 80% of clinical trials still fail to meet enrollment timelines. Diversity gaps remain stark, with trial participation rates among Black (8%) and Hispanic (11%) patients falling far short of their population representation (14% and 19%, respectively). The consequence of this inefficiency is more than just cost; it is time… time that patients waiting for therapies cannot afford.
Over the past decade, our industry has not been idle. We’ve invested in risk-based monitoring (RBM), decentralized trials (DCTs), adaptive designs, compliance oversight, and site optimization strategies. Consolidation has created larger CROs with greater scale. Yet the results remain fragmented. Costs continue to rise, processes remain cumbersome, and diversity and agility improvements are limited. In short, well-intentioned strategies are addressing symptoms rather than root causes.
A Different Way Forward
Incremental improvements will not suffice. What we need is a strategic rethinking of our model. The new paradigm must prioritize smarter, holistic approaches that put patients first, embed agility as a core strategy, and leverage technology as an enabler—not a siloed solution. At Caidya, this shift defines how we partner with sponsors and trial sites.
Rethinking the CRO Model: From Operators to Partners
Too often, CROs are seen as transactional trial operators who are focused on delivering against timelines and budgets, but not truly integrated into the development strategy. I propose that CROs must evolve to become true partners in product development. That means moving beyond incremental fixes to shared goals, integrated teams, and collaborative strategies that amplify outcomes.
Partner-level collaboration enables us to align priorities with sponsors and regulators, co-create solutions with sites, and ensure that every decision is driven by patient benefit. It transforms the CRO from a vendor into a catalyst for accelerating drug development.
Culture of Agility as a Superpower
Agility is not just a buzzword—it is a competitive advantage. Mid-size CROs like Caidya have a distinct ability to pivot quickly, adapt to changes that affect studies in real time, and bring entrepreneurial energy to partnerships. Agility is both structural and cultural. It comes from empowering teams to innovate, leveraging data-driven insights for rapid decisions, and maintaining the flexibility to adjust course when patient needs or regulatory dynamics change.
Agility, when paired with deep expertise and global scale, creates a superpower for sponsors: the ability to move faster without sacrificing quality or inclusivity.
Patients First: Going Where Patients Are
Patient-first design requires more than patient-centric language, it requires structural change in how we plan and execute trials. Too often, studies default to traditional sites, assuming patients will come to us. But patients, especially in rare or underserved populations, often cannot.
In one example, a trial for fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease, shifted its approach. Instead of focusing solely on Western sites, feasibility explored untapped regions. The result was transformative: China emerged as a high-potential region with an enrollment rate twice as high as Western countries, allowing the study to complete ahead of schedule. This is what it means to put patients first—meeting them where they are, not where we assume they will be.
Building a Global Framework
True patient-centricity requires global reach. Caidya has built a distinct global presence, with two decades of experience executing studies in Asia-Pacific. This reach enables us to serve sponsors better by accessing broader patient populations, bringing untapped regions into the clinical research ecosystem, and ensuring that trial designs reflect global diversity.
But global reach alone is not enough. It must be coupled with agility. A flexible global framework allows us to adapt trial models to local contexts while maintaining the speed and quality that sponsors require. It creates the best of both worlds: big enough to access diverse populations, nimble enough to pivot in real time.
Technology as an Enabler: AI and Real-World Data
Artificial intelligence (AI) and real-world data (RWD) offer tremendous potential for improving trial efficiency – accelerating recruitment, designing smarter protocols, enhancing data quality, and building external control arms. Yet without collaboration, agility, and patient orientation, these tools risk becoming another set of disjointed efforts. Technology must be embedded within a broader strategy, aligned with sponsor priorities and patient needs.
Turning Vision into Action
The future of therapeutic development is clear: faster, more flexible, patient-focused, data-driven, and collaborative. The question is not whether we can achieve this, but how. To make this vision real, we must:
- Embed agility as a structural and cultural advantage.
- Build ecosystems of collaboration across sponsors, regulators, CROs, and trial sites.
- Leverage global reach with local adaptability.
- Consistently put patients at the center—meeting them where they are and designing trials that reflect their voice and pathway.
At the Summit, I reminded our audience: you are the architects of what’s next. This is not a passive transition. It requires leadership, courage, and a willingness to rethink entrenched models. The industry has never had greater tools, talent, and opportunities to rewrite the future of patient-centered research. Together, we can make that future a reality.
Barbara Lopez Kunz is CEO of Caidya. This article is based on her keynote presentation at the Florence Healthcare Research Revolution Summit.