Research Operations
Best Practices for IRB Review of DCTs: Expert Perspectives
Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.
Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
Understand the significance of HRPP staffing despite an sIRB mandate, and how HRPP staffing maintains ethical research practices.
Advarra Implements Global Clinical Quality Assessment and Corrective Action Initiatives
Discover how Advarra helped a mid-size R&D device company improve global GCPs and clinical trial quality with tailored assessment and corrective action strategies.
What is a Data Monitoring Committee?
In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.
GxP Best Practices for Safer, Smarter, Faster Clinical Research
Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.
Beginner’s Guide to Human Research Protection Programs
A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.
Tracking an Effective QMS: From Discovery Through Post Study
Explore strategies for sponsors and CROs for implementing an enterprise phased QMS assessment, and address deficiencies in compliance and implement corrective actions.
Optimizing Your Human Research Protection Program: The Role of Quality Training
Having a robust human research protection program (HRPP) in place is vital when maintaining compliance and keeping participants safe.
What is an sIRB and Why Does my Study Need One?
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.
Public Perceptions of Clinical Trials: A Comprehensive Survey
In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.
Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.
sIRB 101: An Introduction to Relying on an External IRB
Learn the basics of working with an sIRB and gain insights for successful sIRB relationships with external IRB partners.
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