Insight Briefs

Delivering expert analysis, strategic takeaways and practical insights.

30 October 2025

Implications of Assessing Overall Survival in Oncology Studies

The FDA’s August 2025 draft guidance reshapes oncology clinical trials by requiring pre-specified overall survival (OS) analysis in...

27 October 2025

The Patient Experience Paradox: eCOA Strategy Overhaul

Discover how the EMA’s new Patient Experience Data (PED) guidance and the EU HTA Regulation are reshaping evidence...

30 September 2025

Automated Evidence Generation for Regulatory-Grade Real-World Data

Manual data abstraction can’t keep up with new FDA and EMA RWE standards. This whitepaper explains how automated...

25 September 2025

The EMR Interoperability Dream vs. Clinical Research Reality
A Practical Guide to the 21st Century Cures Act, FHIR Data, and Bridging the Gap for Regulatory-Grade Evidence

Discover the real-world challenges of EMR interoperability in clinical research. Learn how the 21st Century Cures Act, FHIR...

18 September 2025

ICH GCP E6(R3) Implementation: Practical Approaches and Real-World Considerations

ICH GCP E6(R3) implementation requires strategic planning beyond basic compliance. This practical guide covers realistic 12-18 month timelines,...

16 September 2025

Decentralized Clinical Trial Platforms in 2025: A Practical Guide for Clinical Operations

DCT platform evaluation guide: integration strategies, vendor comparison, implementation timelines for clinical operations teams.

Navigating the eCOA Vendor Landscape in 2025: What Clinical Teams Really Need to Know

The eCOA market reached $2.27 billion in 2025 with 16.1% projected growth, yet vendor selection remains critical for...

Optimizing eCOA in Oncology Trials: Patient-Focused Data Capture for Cancer Research

Oncology leads clinical innovation with 7,747 trials registered through 2022, yet only 7% of cancer patients participate. This...

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