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Good Manufacturing Practices: When Do They Apply?
In the development of a new drug, when do current Good Manufacturing Practices (cGMP) regulations apply? Clinical project teams often struggle with answering this question. In this article, we will discuss the US Food and Drug Administration (FDA) expectations for the application of cGMP to investigational drugs.
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Developing a Data-driven Feasibility Process
Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources can go, assessing a study’s...
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The Regulatory Binder Checklist For Clinical Trial Sites
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents;...
The post The Regulatory Binder Checklist For Clinical Trial Sites appeared first on Advarra.
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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their...
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Navigating Local Considerations When Developing sIRB Reliance Policies
In recent years, the use of single institutional review board (sIRB) review has gained significant traction in the world of...
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GxP Audits Guide for Successful Clinical Trials
A well-designed GxP audit program, in addition to satisfying the regulatory requirement of sponsor oversight, allows for early detection of...
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Impact of sIRB Mandates on Study Teams
Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...
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Strategic Training: Navigating Organizational Challenges
It seems as if everything now is requiring a training for something. In reality, is it needed? While training is...
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Key Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.
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Planning for Complex Change at Your Organization
The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational...
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