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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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The Impact of GCP R3 on Your Trial Master File
Introduction The third revision (R3) of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) was...
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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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Deviations in Medical Device Clinical Studies
Introduction During the conduct of a study, there may be instances where the study protocol is not...
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Strategizing Biocompatibility Evaluation in Changing Manufacturing Environments: When do you Approach Subject Matter Experts?
In a dynamic manufacturing environment, changes are inevitable. Ensuring medical device safety is very crucial, particularly when...
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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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Surface Morphology: A Case Study On Implantation Endpoint
In a previous blog post, we highlighted the essential role of surface characterization in ensuring the biocompatibility...
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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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Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 2 of 2
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
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