Newsletter | July 29, 2026

07.29.26 -- Hybrid Models, Disease Modification, And Comparator Sourcing: This Week In Clinical Trials

DECENTRALIZED TRIALS

Where The FDA And EMA Stand On Digital Endpoints

In part two of this series on digital endpoints, consultant Anita Burrell reviews the extent of their regulatory acceptance and discusses how to ensure data produced from digital technologies satisfies regulators.

Hybrid Ophthalmic Trials: Splitting Visits Across Home, Hub, And Site

Hybrid ophthalmic trials combine in-person and remote visits, boosting patient convenience, reducing site burden, and accelerating timelines while maintaining data quality and compliance.

TRIAL MANAGEMENT

Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension

Cereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.

Operationalizing Immuno-Oncology Studies

Managing CRS and immune risks demands early detection, rapid response, and skilled teams. Strong infrastructure and clear protocols enable safer immunotherapy trials beyond academic centers.

Comparator Selection And Supply: Best Practices For Clinical Success

Explore best practices for comparator selection and supply optimization in clinical trials, including sourcing strategies, risk mitigation, regulatory compliance, and real-world cost-saving case studies.

Designing Clinical Packaging For A New Era Of Trial Complexity

See how innovative packaging engineering approaches are helping study teams adapt to evolving clinical trial requirements with greater speed and flexibility.

Purposed-Built For ADC Development

Bispecific ADCs are reshaping cancer care. Early-phase development is critical, requiring agile CRO support, scientific depth, and real-time data to guide biotech sponsors toward long-term success.

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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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