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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,...
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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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