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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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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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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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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Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 1 of 2
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
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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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Leveraging Surface Characterization: Emerging Trends in Biocompatibility Tests
Finding the least burdensome pathway to address biocompatibility requirements can be a challenge. Coupling our engineering and...
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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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Decentralized Clinical Trials
Decentralized clinical trials (DCTs) are becoming increasingly popular, with the increased use of electronic systems and novel...
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