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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Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 1 of 2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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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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