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Developing a Quality System / Standard Operating Procedures for Conducting Medical Device Clinical Trials
Introduction The development of quality system procedures or standard operating procedures (SOPs) for conducting clinical trials of...
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A Brief History of the Development of Clinical Research Principals, Guidelines, and Regulations
Hippocratic Oath The Hippocratic Oath was likely written between the 5th and 3rd centuries BCE. Its purpose...
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5 Aspects of Device Clinical Study Close-Out
A clinical study process that is often underappreciated is close-out. Regardless if the study was completed or...
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Completing clinical study enrollment and what’s next
Great job on completing enrollment! Reaching this major milestone is a big accomplishment as it marks the...
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Understanding the Key Players in a Clinical Research Trial
In a clinical research trial, or study, various roles are crucial to ensuring the study’s success and...
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Artificial Intelligence in Clinical Studies
Artificial Intelligence (AI) is a growing field of interest for many industries, including those of medical devices...
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Selecting the Right Electronic Data Capture (EDC)
What is EDC? EDC stands for electronic data capture. This usually refers to the processes of an...
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Phases and Stages of Clinical Trials
Clinical research for pharmaceuticals and devices follows the same general path. The first trial is a small...
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The Value of a Clinical Events Committee (CEC)
What is a CEC? In clinical trials that include a high-risk patient demographic, a clinical events committee...
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The Power of Post-Market Clinical Data
For medical devices, ensuring safety and efficacy doesn’t stop once a product hits the market. Post-market clinical...
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Clinical Site Selection: Navigating the Complexities of Clinical Trial Success
Selection of an investigational site for a clinical trial is critical to success. Throughout a clinical trial,...
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Clinical trial monitoring
Monitoring Clinical trial monitoring is a constantly evolving field, now encompassing various approaches that work together to...
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