Global by Design: What 2026 Means for Sites, Sponsors, and Trial Operations

As clinical trials become more global, technology-enabled, and operationally complex, sponsors are facing a familiar tension: how to scale faster without overwhelming sites. Insights from Kevin Williams of Ledger Run, alongside broader industry data on global clinical development, suggest that 2026 will be defined less by adding new tools and more by rethinking operating models, systems, and partnerships.

What operational changes are sponsors considering to better support sites in 2026?

From an operational standpoint, sponsors are reexamining how services are delivered across trials. Williams noted that one of the core questions sponsors are asking is whether to rely on full-service CROs, multiple CROs, or more functionally standardized models. These decisions increasingly involve both organizational structure and the systems used to support trial execution.

Why are operating model choices so closely tied to site burden?

Sites often work with multiple sponsors and CROs simultaneously, each using different processes and systems. This creates a “switching burden,” where site staff must constantly adapt—logging into multiple platforms and navigating inconsistent workflows. Williams emphasized that this operational switching is a persistent challenge that sponsors need to factor into decisions about sourcing and system changes.

Are sponsors moving work back in house?

Yes. Sponsors are actively exploring what “in house” means in practice. In some cases, this involves functional sourcing rather than outsourcing entire programs to CROs. In others, it involves implementing new systems—or a combination of both. The trend reflects a broader effort to regain control over operations while managing complexity across trials.

How does global expansion complicate operational decisions?

Global clinical development has become highly regulated, geographically diverse, and technology-driven. Emerging markets now account for a growing share of trial starts, led by Asia-Pacific and China. As trials span more regions, operational decisions must account for regulatory variation, infrastructure differences, and site capabilities across countries.

Why are emerging markets playing a larger role in clinical trials?

Countries such as India, Brazil, and Colombia have become major destinations for clinical research due to large patient populations, expanding economies, and improving healthcare infrastructure. Asia-Pacific has shown the most dramatic growth, with China increasing its share of total trial starts from 8% in 2013 to 29% in 2023. Lower-middle-income countries have also seen a significant rise in newly recruited studies.

How are decentralized and hybrid trials changing global execution?

Decentralized and hybrid trial models are accelerating global participation and access. The majority of research sites have now adopted at least one decentralized method, and hybrid trials combining remote and in-person visits are widespread. Emerging markets have been particularly effective in deploying flexible hybrid models that reduce infrastructure constraints and improve patient access.

What role does technology play in reducing—or increasing—site burden?

Technology platforms are rapidly evolving to support global and decentralized trials, from site feasibility and patient recruitment tools to automated clinical supply systems. While these tools can streamline execution, Williams cautioned that introducing new systems without considering interoperability and workflow alignment can increase switching burden for sites rather than reduce it.

How are CRO relationships evolving alongside these changes?

The CRO industry has shifted from transactional outsourcing to strategic partnerships. Modern CRO relationships increasingly involve shared responsibility for innovation, technology integration, and global execution. This evolution reflects the growing complexity of trials, particularly in specialized areas such as cell and gene therapy and decentralized study models.

Why is functional standardization becoming more important?

As sponsors operate across multiple regions and partners, functional standardization offers a way to reduce variability for sites. Standardized processes and systems can help limit unnecessary operational switching, even when multiple CROs or partners are involved.

What regulatory trends are shaping global trial operations?

Regulators are increasingly aligning globalization with patient safety, data integrity, and diversity requirements. FDA guidance clarifies that decentralized trials must meet the same standards as traditional onsite trials, while diversity action plans and EU regulations are raising expectations for inclusion and cross-border data management. These requirements add operational complexity but also reinforce the need for consistent, well-supported site workflows.

How do decentralized trials affect quality management?

Distributed trial networks require robust quality management systems to maintain compliance and data integrity. Evidence from decentralized trial implementations shows improved adherence to timelines and greater demographic diversity compared with traditional models, underscoring the importance of operational discipline alongside flexibility.

What skills and capabilities are organizations building to manage this shift?

Organizations are investing in cross-functional teams with expertise in global regulations, decentralized methodologies, and technology integration. Training efforts increasingly emphasize digital literacy, regulatory navigation, and cultural competency, as sponsors work to support sites operating in diverse healthcare environments.

Why are partnerships critical to supporting sites at scale?

Strategic partnerships with CROs, technology vendors, academic institutions, and community organizations provide access to infrastructure, expertise, and patient populations that sponsors cannot build alone. These collaborations are especially important in emerging markets, where trust, cultural understanding, and local engagement are essential to successful trial execution.

What does all of this signal for clinical operations in 2026?

The convergence of global expansion, decentralized models, and evolving operating structures suggests that 2026 will be less about introducing new tools and more about reducing friction for sites. Sponsors that align operating models, systems, and partnerships around consistency and usability will be better positioned to scale trials without adding unnecessary burden.

Taken together, these trends point to a pivotal shift in clinical operations—one where supporting sites effectively becomes a prerequisite for global growth, rather than a downstream consideration.

Editor’s note: This FAQ article was generated based on two previous pieces of Applied Clinical Trials content—Rethinking Operational Models to Reduce Site Burden in 2026 and The Evolution of Global Trial Strategies in Today's Complex Healthcare Landscape.