Tag: real-time monitoring]

Managing Complex Data Collection Tools in Small Cohorts

August 17, 2025

Managing Complex Data Collection Tools in Small Cohorts Optimizing Data Collection Tools for Small Patient Populations in Rare Disease Trials Why Small Cohort Trials Present Unique Data Collection Challenges Rare disease clinical trials typically involve small cohorts—sometimes fewer than 20 patients—making every datapoint crucial. These studies often require complex data collection tools to capture nuanced,…

Operational Challenges, Rare and Orphan Disease Trials

Using Real-World Data to Inform Disease Progression in Rare Conditions

August 13, 2025

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Using Real-World Data to Inform Disease Progression in Rare Conditions Leveraging Real-World Data to Understand and Model Disease Progression in Rare Diseases Introduction: The Value of Real-World Data in Rare Disease Trials Understanding disease progression is one of the foundational steps in rare disease clinical research. However, the scarcity of patients, heterogeneity in symptoms, and…

Natural History Studies, Rare and Orphan Disease Trials

Addressing Protocol Deviations During Monitoring Visits

June 23, 2025

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How to Address Protocol Deviations During Monitoring Visits Protocol deviations are unintended departures from approved study procedures, and they can occur at any site during a clinical trial. During routine monitoring visits, Clinical Research Associates (CRAs) are responsible for identifying, documenting, and helping resolve such deviations. Proper handling of protocol deviations is crucial for ensuring…

Routine Monitoring Visits, Site Management and Monitoring