Castor
Insight Briefs
ICH E6(R3) Annex 2
ICH E6(R3) Annex 2, adopted 3 June 2026, establishes Good Clinical Practice standards for trials that use real-world data. Learn more
UK clinical trial regulations reform 2026
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (SI 2025/538) came into force on 28 April 2026. Learn more
Global eConsent Country Readiness Guide 2025
Electronic consent is now approved or conditionally approved in 27 of 33 countries assessed in Castor's eConsent Country. Learn more
The 2027 RWE Playbook
Most RWE programs weren't built for 2027. They were built for 2019 — before FDA issued device-specific guidance. Learn more
Trust LLMs with Chart Review: Validation Framework
Most AI chart review vendors oversell accuracy and ignore the pipeline problem entirely. Learn more
The eCOA Iceberg: uncovering the hidden costs of software-only models
SaaS eCOA looks cheaper on paper. This guide exposes five hidden costs that change the full-service vs. software-only dynamics. Learn more
The ePRO blueprint for pain trials: Optimizing data capture from protocol design to efficacy endpoints
The 11-point electronic Numeric Rating Scale (eNRS) is now the preferred digital standard for BYOD pain trials. Learn more
Obesity RWD Compliance: The Direct-to-Patient Guide
Over 2,000 active obesity and GLP-1 studies are competing for the same patients. Learn more
Own Your Data, Accelerate Your Cure Castor Catalyst — Rare Disease Insight Brief
Rare disease foundations no longer need to wait for pharmaceutical industry interest to develop treatments for their communities. Learn more
The real-time monitoring dilemma
Offline eCOA capability creates regulatory tension with EMA device-as-source requirements. Learn more
Is Your eCOA UAT Stuck in Time?
Modern clinical trials increasingly rely on complex, time-sensitive logic within eCOA systems. Learn more
The End of the “PRO Tax”: Top 10 Commercial PROs & their cost-effective alternatives
The clinical trial industry faces a "PRO Tax"—the high costs and operational delays associated with licensing and implementing. Learn more
The Silent Saboteurs: Why Rater Drift and Site Unpreparedness Cost CNS Trials More
CNS trials fail not from technology limitations but organizational factors. Learn more
Hospital-Based eCOA Implementation: Real Challenges in Infectious Disease Trials
Hospital-based infectious disease trials face unique eCOA implementation challenges including IT security delays. Learn more
Implications of Assessing Overall Survival in Oncology Studies
The FDA’s August 2025 draft guidance reshapes oncology clinical trials. Learn more
The Patient Experience Paradox: eCOA Strategy Overhaul
Discover how the EMA’s new Patient Experience Data (PED) guidance is reshaping evidence. Learn more
Automated Evidence Generation for Regulatory-Grade Real-World Data
Manual data abstraction can’t keep up with new FDA and EMA RWE standards. Learn more
The EMR Interoperability Dream vs. Clinical Research Reality
Discover the real-world challenges of EMR interoperability in clinical research. Learn more