Newsletter | September 30, 2026

09.30.26 -- Old Trial Playbooks Are Breaking Under New Complexity

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Join our webinar on October 22, 2026, at 11 AM ET to learn how to successfully execute adaptive trials. We will explore key impacts on sites, data, technology, supply, and teams. Don't let adaptation turn into disruption—register today to secure your spot! Registration is free.

TRIAL MANAGEMENT

 

The Rare Trials Summit Wants To Produce More Than Conversation

The Rare Trials Summit returns to Boston this September with a mission that extends beyond traditional conference presentations. Through interactive workshops and working groups focused on regulatory guidance and pediatric trials, organizers hope to produce practical solutions that help advance rare disease clinical research.

 

To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures

UNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.

 

Clinical, Commercial Packaging: Delivering Next-Gen Therapies

See how strategic, agile, and sustainable packaging is transforming drug delivery into a key driver of speed, safety, and patient-centric innovation.

 

Mastering Clinical Trial Forecasting Through Continuous Learning

Stop treating trial budgets as fixed predictions. Discover how top teams refine financial forecasts by tracking shifting assumptions to improve governance and build trust.

 

Whole Health In Action: Real-World Examples Of Better Outcomes

Whole health looks beyond traditional care by addressing food access, environment, and lived experiences—leading to healthier communities and more holistic outcomes.

 

How Drug Pooling Improves Supply Efficiency Across Your Portfolio

p> Learn how pooled inventory strategies help sponsors maximize drug utilization while maintaining control, traceability, and operational efficiency.

 

 

Beyond The Benchmark: Innovative Trial Designs Transform Research

Adaptive designs, decentralized models, and AI insights are reshaping trials — boosting efficiency, speeding timelines, and strengthening evidence amid evolving regulations and funding pressures.

 

Unique IRT Considerations For Personalized Medicine Trials

The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.

DECENTRALIZED TRIALS

 

Bridging Community And Central Hospitals With Japan's DCT Model

Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan, explains consultant Takuma Matsunaga.

 

Balancing Patient Convenience And Signal Integrity In CNS Trials

Early CNS trials depend on precise data. Hybrid approaches can reduce participant burden, but critical assessments often require controlled environments to preserve signal integrity.

 

Reducing The Burden Of Patient Retention And Improving Continuity

Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.

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