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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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The Power of Post-Market Clinical Data
For medical devices, ensuring safety and efficacy doesn’t stop once a product hits the market. Post-market clinical...
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EU MDR Article 61 Clinical Evaluation
The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of...
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Challenges of Demonstrating Biological Equivalence per ISO 10993-18 and EU MDR
In the European Union (EU), a device is considered equivalent if it fulfills all the requirements of...
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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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Clinical Site Selection: Navigating the Complexities of Clinical Trial Success
Selection of an investigational site for a clinical trial is critical to success. Throughout a clinical trial,...
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Applying for Grants to Secure Funding
Preparing and applying for scientific grants can be laborious, time consuming, and laden with hurdles. This is...
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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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B1+RMS limits on MR Conditional labeling
European notified bodies have recently started requiring B1+RMS limits on MR Conditional labeling. This requirement stems from...
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