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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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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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5 Main Components of a MDR Clinical Evaluation Report (CER)
To comply with the European Union Medical Device Regulation (MDR), medical device manufacturers are required to conduct...
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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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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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CRO selection: How to get it right the first time
CRO selection can sometimes be difficult to navigate. “My favorite meeting to have with a CRO is...
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Modern Tools for Decentralized or Virtual Clinical Trials
Modern Tools for Decentralized or Virtual Clinical Trials Advances in web-based and mobile technologies have led to...
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Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
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Hybrid Clinical Trials in the Age of COVID-19 and Beyond
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
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Clinical Trials for Medical Device Innovators Part V: Important Points
The fifth and final, in a blog series about clinical trials for medical device innovators. Read part...
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Cost Drivers for Clinical Trials: Clinical Trials for Medical Device Innovators Part IV
Cost Drivers for Clinical Trials: Clinical Trials for Medical Device Innovators Part IV. The fourth, in a...
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