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Real-World Data Are Everywhere. Useful Real-World Evidence Takes Planning
For many sponsors, real-world data can be both an opportunity and a risk. The right data source...
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From Published Clinical Evidence to Market Authorization
Expanding the intended use of a medical device in the United States is often assumed to require...
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ISO 14155:2026 Changes
Introduction to ISO 14155 The International Organization for Standardization (ISO) develops independent, international standards in various sectors...
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Overcoming the Challenges of Biological Product Development in a Complex Regulatory and Economic Landscape
What are Biological Products? A biological product or “biologic” is a broad term for living material-derived larger...
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Leveraging Clinical Data to Support Reimbursement
Got data? Data from clinical studies, registries, and medical record review supports reimbursement pathways by demonstrating a...
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Medical Imaging in Clinical Trials
Medical imaging is a routine practice for healthcare professionals. The images produced are used as a clinical...
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Clinical Trials: Monitors and Research Coordinators
In the intricate world of clinical trials, the relationship between a clinical trial monitor and a research...
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Improving Efficiencies in Data Collection: Electronic Source
Introduction to Source Documentation Source documentation is the initial documentation of clinical trial data, regardless of format...
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Good Documentation Practices for a Clinical Trial
Source documents are essential documents that are required for Good Clinical Practice. It is the first place...
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How to Start a Clinical Trial: 10 Steps to Meet FDA Standards
Starting a clinical trial is a critical milestone in bringing new medical products to market. Whether you...
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Rethinking Representation in Clinical Research – Who’s in the Study?
Introduction The underlying principle of a clinical study is to assess the safety and efficacy of an...
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Patient-Reported Outcome (PRO)
“What matters is this – will it help patients?” ~ Bill Cook Introduction To ensure that patients...
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