Newsletter | August 27, 2026

08.27.26 -- Patient Data Breaks Down When Trial Systems Miss Reality

PATIENT EXPERIENCE: THE ECOA USABILITY PROBLEM

eCOA Data Quality Breaks Down Before Patients Ever Enroll

Patient-centered eCOA design, cultural adaptation, and usability testing help prevent avoidable data gaps, reduce burden, and protect trial quality.

 

DATA, EVIDENCE, AND TRIAL OPERATIONS UNDER PRESSURE

FDA’s New RWE Standards Raise The Stakes for Sponsors

FDA guidance is raising expectations for real-world evidence. Learn why interoperable, audit-ready data infrastructure is critical for defensible submissions.

What Site Source Document Workflows Reveal About Delays

Global research reveals how sites prepare source documents, where friction occurs, and how better workflows can reduce delays and improve data quality.

Mid-Study IRT Changes Without Compromising Data Integrity

See how teams can implement randomization mid-study by rebuilding subject and inventory records without disrupting sites or compromising data integrity.

How One Pharma Scaled Oncology Trials Without Losing Speed

See how a top-10 pharmaceutical company scaled concurrent oncology trials while maintaining the operational agility needed in a rapidly changing market.

Why Patient-Centered Research Needs HEOR More Than Ever

Explore how HEOR can help research reflect patient priorities, strengthen evidence generation, and improve decision-making across healthcare.

TOOLS TO REDUCE TRIAL FRICTION AND RISK

Eliminate Paper Binders To Speed Clinical Trial Workflows

Why RTSM Recognition Matters For Clinical Trial Delivery