Download the full 2026 Clinical Trials Trends Report here.

This free industry report outlines industry perspectives and expert advice from our team of life sciences consultants. You can view an excerpt of the report below, and if you’d like to discuss any of the trends or other challenges in the clinical trials space, connect with our team today.

Key Clinical Trials Trends

Clinical trials in 2026 will highlight the growing importance of operational strategy in translating research into patient outcomes. The separation between science and execution is narrowing as organizations recognize that performance in the field determines success in the lab. Clinical operations now serves as the structural core connecting data systems, vendor relationships, and supply logistics. Leadership buy-in for technology investment and data-driven planning will be essential to sustain this progress. Biotech teams that modernize processes and integrate regulatory planning early will gain the adaptability needed to manage rising trial complexity. 

Clarkston’s life sciences consultants have highlighted the top clinical trials trends that businesses should consider and keep top-of-mind throughout the year:

1. Legacy processes strain under new models
2. Integrated roadmaps replace siloed operations
3. Operational data becomes the new currency
4. Supply chains gain strategic importance
5. Vendor consolidation reshapes partnerships

Trend 1:

Legacy processes strain under new models

Hybrid and decentralized trials are now standard, but many organizations continue to rely on systems designed for traditional site-based studies. Remote visits and home sampling offer flexibility for participants but expose inefficiencies in procedures built for slower trial formats. Standard operating procedures (SOPs) and monitoring plans must be rewritten to reflect modern oversight that is risk-based and remote. 

These challenges appear in three core areas: SOPs, data-driven decision making, and IT roadmaps. Many teams depend on paper-heavy SOPs that cannot adapt to faster timelines. Decision frameworks remain fixed, even though trials now produce continuous operational data that requires active management.  

Legacy technology further limits agility. Integrations that rely on nightly uploads are being replaced with event-driven APIs that support near real-time workflows and reduce manual reconciliation. Despite this, many biotech companies still depend on fragmented CTMS tools or spreadsheets, creating operational blind spots. A clear IT roadmap, one that aligns with trial design and patient engagement strategy, is critical. 

Sponsors that don’t modernize face risks of delayed start-up timelines or poor retention. As regulators adjust expectations for decentralized studies, process owners must create compliant workflows that protect data integrity while supporting patient needs. In 2026, success will depend on recognizing clinical operations as a strategic pillar rather than a procedural step.  

Trend 2:

Integrated roadmaps replace siloed operations

Biotech teams are realizing that isolated functions and disconnected vendor systems can no longer sustain the complexity of modern research. Adaptive designs require coordination between protocol design and site management. Sponsors now create unified operational roadmaps before selecting vendors to align trial design with delivery. Real-time visibility into study progress has become essential for maintaining quality. 

Centralized orchestration platforms are replacing manual handoffs that cause inefficiency across functions. These systems allow clinical and regulatory groups to plan from a shared foundation. Historically, roadmaps concentrated on scientific milestones such as protocol approval or first-in-human studies, while regulatory preparation came later. In 2026, that sequence is changing. Organizations are embedding regulatory planning and regional sequencing into early operational roadmaps to anticipate approval pathways and market access. 

Incorporating regulatory strategy early helps ensure that decisions on site selection or data standards directly support both execution and future review. This integration reduces late amendments, shortens activation timelines, and builds confidence with investors and patients. Teams using integrated roadmaps report measurable efficiency gains because dependencies are identified and funded in advance. 

Continue reading by downloading the full report below.

Download the Full 2026 Clinical Trials Trends Report Here

Read last year’s Clinical Trials Trends Report here.

Contributions from Hannah Yang