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Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
If there’s one constant in clinical research, it’s change. With continual innovations and transformations, establishing a human research protection program...
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What is a Data Monitoring Committee?
Clinical trials receive a lot of oversight from regulatory agencies, as well as independent committees reviewing different aspects of the...
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GxP Best Practices for Safer, Smarter, Faster Clinical Research
In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy,...
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Beginner’s Guide to Human Research Protection Programs
Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and welfare of research participants. A...
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Optimizing Your Human Research Protection Program: The Role of Quality Training
As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is...
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What is an sIRB and Why Does my Study Need One?
For decades, many research sites have primarily relied on institutional review board (IRB) oversight provided by committees that are administered...
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Public Perceptions of Clinical Trials: A Comprehensive Survey
The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight...
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Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for...
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How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
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Understanding Various Site Use Cases for eSource and EDC
Efficient and compliant data capture can make or break the success of a clinical research trial. Utilizing a comprehensive, site-centric...
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