Research Operations
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.
Understanding Various Site Use Cases for eSource and EDC
Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
Unlocking Global Potential: Partnering Across Varying Sites in Study Startup
Join us as Advarra experts outline how sponsor organizations can work with various site types across trials and adapt their resources accordingly.
Clinical Research Training: A Blended Approach
Listen now and hear how this approach accelerated the learning curve and fostered a productive environment for integrating the OnCore CTMS.
Reporting Unexpected Incidents to the IBC
Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.
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