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Data Safety Monitoring Boards Facilitate Ethical Research
In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant...
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What Sponsors Need to Know About Medicare Coverage Analysis
The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial...
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Collaborating with Research Sites: Best Practices for Site Selection and Study Startup
The study startup process is a critical point in research, and oftentimes, can make or break a study’s success. Sites,...
The post Collaborating with Research Sites: Best Practices for Site Selection and Study Startup appeared first on Advarra.
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Key Efficiencies Driven by a Clinical Trial Management System
In today’s world of research, using a clinical trial management system (CTMS) can significantly streamline operations, and make for a...
The post Key Efficiencies Driven by a Clinical Trial Management System appeared first on Advarra.
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Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and...
The post Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research appeared first on Advarra.
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Beginner’s Guide to IRB Review of IVD Research
In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., blood or tumor tissue) to diagnose diseases or...
The post Beginner’s Guide to IRB Review of IVD Research appeared first on Advarra.
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Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges
Effective participant recruitment is crucial to a successful clinical trial, but recruiting eligible participants in sufficient numbers has long been...
The post Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges appeared first on Advarra.
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Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular...
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How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater...
The post How Single IRB Review Mandates Help Research Sponsors appeared first on Advarra.
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Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs...
The post Top 3 Reasons Why Your Medical Device Needs a Clinical Trial appeared first on Advarra.
