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Our OnCore CTMS Vision: Building a Foundation for Success
More than two decades ago, we created the OnCore clinical trial management system (CTMS) to serve as a comprehensive solution...
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Unpacking The Role of a Right-Sized QMS in Study Startup
The study startup process involves a multitude of tasks and activities multiple teams coordinate to ensure the successful study initiation....
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A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study....
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Thinking About the Box: Considerations for Transport of Investigational Products
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires...
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Clinical Trial Startup: Insights from the Industry
The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology,...
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The Role of Financial Management and GAAP in Clinical Research
Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall...
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Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry,...
The post Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance appeared first on Advarra.
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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...
The post Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate appeared first on Advarra.
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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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