Real-World Evidence (RWE) & Observational Studies

Aligning Safety Monitoring in Observational Studies With Regulatory and HTA Expectations In recent years, the importance of safety monitoring in observational studies has garnered significant attention in the realms of regulatory affairs, healthcare technology assessment (HTA), and clinical research. As laws evolve, regulatory agencies such as the FDA, EMA, and MHRA are increasingly focused on…

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Common Biases in Safety Monitoring in Observational Studies—and How to Correct Them Common Biases in Safety Monitoring in Observational Studies—and How to Correct Them This tutorial guide aims to provide a detailed overview of the common biases encountered during safety monitoring in observational studies, particularly in the context of good labs clinical trials. As clinical…

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Safety Monitoring in Observational Studies in Practice: Step-by-Step Guide for Real-World Researchers Safety Monitoring in Observational Studies in Practice: Step-by-Step Guide for Real-World Researchers Introduction to Safety Monitoring in Observational Studies Observational studies represent a significant part of clinical research, particularly in understanding real-world evidence and gathering data on treatment outcomes. Safety monitoring is crucial…

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How to Design Safety Monitoring in Observational Studies for FDA, EMA and HTA Acceptance How to Design Safety Monitoring in Observational Studies for FDA, EMA and HTA Acceptance Safety monitoring in observational studies plays a crucial role in ensuring the reliability and integrity of clinical data. For clinical operations, regulatory affairs, and medical affairs professionals…

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Safety Monitoring in Observational Studies: Best Practices for High-Validity Real-World Evidence Safety Monitoring in Observational Studies: Best Practices for High-Validity Real-World Evidence Safety monitoring is a critical aspect of conducting observational studies, particularly in the context of clinical trials associated with diseases such as bladder cancer. As the demand for real-world evidence (RWE) increases, it…

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Data Models, Standards and Metadata Needed for Strong Safety Monitoring in Observational Studies As the landscape of clinical research continues to evolve, the need for robust safety monitoring in observational studies becomes paramount. This guide is designed to provide clinical operations, regulatory affairs, and medical affairs professionals with a structured approach to employing data models,…

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Integrating Safety Monitoring in Observational Studies With Clinical Trials, RCTs and Hybrid Designs Integrating Safety Monitoring in Observational Studies With Clinical Trials, RCTs and Hybrid Designs Safety monitoring is a crucial aspect of clinical research, especially when integrating observational studies with clinical trials. As regulatory frameworks evolve, it is vital for clinical research professionals to…

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