Regulatory Acceptance of EHR-Derived Data in Pharma Studies
Agencies such as the FDA and EMA are open to the use of EHR data, provided the following criteria are met:
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Real-World Evidence (RWE) and Observational Studies
AI and NLP Applications in EHR Data Mining for Real-World Evidence
EHR systems contain:
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Common Data Models for EHR Integration in Real-World Evidence Studies
Inconsistent EHR formats across healthcare systems hinder large-scale observational studies. CDMs solve this problem by:
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Site Selection Based on EHR Feasibility Analysis in Clinical Trials
Using EHRs for site selection offers distinct advantages:
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Overcoming Data Quality and Completeness Challenges in EHR-Based Research
Several recurring problems can affect the reliability of EHR data in clinical trial planning and RWE generation:
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Using EHRs for Real-World Safety Signal Detection in Pharmacovigilance
A safety signal is a hypothesis-generating alert indicating a possible causal relationship between a drug and an adverse event. Early detection of these signals can help prevent widespread harm, guide regulatory actions, and inform risk mitigation strategies. Traditionally, safety signal detection relied heavily on spontaneous reports, but these are often delayed, incomplete, or underreported.
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