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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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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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Regulatory Challenges for Novel Implantable Devices under EU MDR
In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...
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A Quick Guide to the EU IVDR
The In Vitro Diagnostic Directive (EU) 98/79/EC (IVDD) was introduced over two decades ago to establish the...
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The Growth of Digital Health Technology for Patient Reported Outcomes in Clinical Trials
An update to our blog about how digital health technology is optimizing the clinical research industry. Introduction...
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Navigating Biocompatibility: An Introduction to ISO 10993 Series of Standards
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
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Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions
FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party...
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FDA’s New Guidance on Nitrosamine and Nitrosamine- Drug Substance Related Impurities and Recommended Acceptable Intake Limits
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
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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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An important downside to eSTAR
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
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On the Record: Compliance with 21 CFR Part 11 in Clinical Trials
What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
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