The clinical research landscape is shifting faster than anyone expected. Rising costs, tougher competition for sites, and ongoing talent shortages mean sponsors are under pressure to rethink their approach to trial execution. The question isn’t if things need to change, it’s how.

This reality was the focus of a recent BioStock interview with Hanna Sandvall, VP, Strategic Resourcing Solutions, and Estelle Guiheneuf, Interim Head of Oncology at TFS HealthScience. Together, they outlined how adaptability and innovation are shaping the next generation of clinical trials, and why flexible approaches are becoming essential.

In this blog, we highlight their key insights on sourcing strategy, oncology trial complexity, the role of AI, and the advantages of working with a mid-sized CRO.

With tighter budgets, leaner teams, and more complex studies, sponsors need flexible models that can grow with them instead of locking them into rigid systems.

Strategic Resourcing in Action

One of the most significant shifts in the market is the transition toward hybrid and functional service provider (FSP) models. These approaches are gaining traction not just because they help control costs, but because they create breathing room for sponsors to stay focused on the science.

The key is aligning resources with the trial’s actual needs. In early phases, smaller, highly specialized teams might suffice, while later phases often demand broader infrastructure and more oversight. It’s the difference between needing a quartet versus a full orchestra, and getting that balance right saves both time and money.

This type of flexibility also helps sponsors avoid one of the most common pitfalls: overinvesting too early. By scaling in line with development, resources stay aligned with strategy rather than surpassing it.

Partnerships That Function Like One Team

Beyond efficiency, partnerships are essential for trial success. Hanna emphasized that the best collaborations aren’t just transactional; they’re rooted in cultural fit, consistency, and shared responsibility.

The most effective partnerships function as a single team, with shared KPIs, dedicated oversight, and trust at the core.

That same principle holds even more significance in oncology and hematology, where complexity is standard. As Estelle often sees, many emerging biotechs are still building their site and investigator networks, which is a completely normal gap during early growth stages. The right CRO can help fill this gap by providing therapeutic expertise and established site relationships, ensuring feasibility is grounded in reality and trials are positioned for success.

The Role of AI in Modern Trials

AI is also beginning to transform how feasibility and trial design are approached. Predictive modeling, for instance, can speed up site selection and resourcing, reducing ramp-up times from weeks to hours. These tools don’t replace human judgment but support it, enabling sponsors to act more quickly and confidently.

In oncology, the applications are even broader. Synthetic control arms help reduce dependence on traditional control groups, while AI-powered analyses of historical and real-world data refine eligibility criteria and simplify endpoints before enrollment begins. These innovations hold the potential to shorten timelines and improve trial feasibility without sacrificing rigor.

But as Estelle pointed out, there are limits to what AI can do today. Regulatory agencies demand transparency, and that’s where so-called black box algorithms pose challenges. These are AI systems that produce outputs without clearly showing how those outputs were generated. In clinical research, this lack of explainability is more than just an inconvenience; it raises compliance, safety, and ethical concerns. Sponsors, regulators, and patients must trust and verify every decision that impacts a trial, from site selection to patient eligibility. Until AI systems can offer that level of clarity, their use will remain carefully scoped.

Despite these limitations, AI is establishing practical roles that deliver real value by helping teams accelerate progress, manage data more efficiently, and design smarter trials while prioritizing patient safety and regulatory compliance.

The Mid-Sized Advantage

Mid-sized CROs hold a unique position in today’s clinical research landscape. Large global players often have extensive infrastructure but can be hampered by bureaucracy and inflexible systems. Smaller niche providers, however, may be more agile but lack the reach or resources to manage complex, multi-country programs.

A mid-sized partner offers a balance between the two. With global capabilities and therapeutic depth, yet without the layers of red tape that slow larger organizations, mid-sized CROs can adapt quickly to shifting study demands. That agility becomes especially valuable in oncology and hematology, where recruitment patterns, data volumes, and site dynamics can change overnight.

Estelle highlighted that this balance makes a tangible difference for sponsors. Complex trials don’t always follow the script, and the ability to scale teams up or down without losing oversight helps studies maintain momentum. For emerging biotechs especially, it means access to both the infrastructure needed to compete globally and the flexibility to shape solutions around their specific pipeline.

Keeping Patients at the Center

Amid conversations about resourcing models and emerging technologies, both Hanna and Estelle returned to the same point: patients must remain the focus.

For Hanna, that means keeping trial design and operations purposeful and straightforward. Over-engineering processes or adding layers of complexity rarely delivers value. Instead, aligning models to the trial’s phase and patient population is where sponsors can see the greatest impact.

Estelle echoed the sentiment from a scientific perspective. For her, the real measure of innovation is whether it accelerates the delivery of new treatments to the people who need them most. Technology and partnerships only matter if they help bring therapies to patients faster, smarter, and more reliably.

Together, their advice reinforces a guiding principle: adaptability, strong partnerships, and patient focus are not just nice-to-haves in today’s environment; they are essential to delivering better outcomes.

The Path Forward for Sponsors

Clinical research is entering a new era where flexibility, innovation, and collaboration define success. Whether it’s right-sizing teams, applying AI where it truly adds value, or navigating the complexity of their trials, sponsors need partners who can adapt quickly without losing sight of patients.

That balance — between science and operations, agility and scale, technology and trust — is where progress happens. Watch the full BioStock interview with Hanna and Estelle to hear more on how adaptability and innovation are reshaping clinical trials.