Research Compliance
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.
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.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
Device Risk Determinations for IVD Research
Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.
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.
New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
Explore insights on new CMS policies & Medicaid's fresh clinical trial policy. Stay updated in a rapidly evolving healthcare landscape.
Phases of Clinical Research: A Detailed Overview
Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.
Ace Your Next FDA Inspection
Discover valuable insights and expert guidance on navigating FDA inspections in clinical research.
Advantages and Considerations for an eRegulatory Implementation
Gain an understanding of what an eReg system is and the features available to streamline clinical trial regulatory management.
Biotech Organization Partners with Advarra to Become Inspection Ready
A biotech organization becomes inspection ready through Advarra's GxP services and successful U.S. Food and Drug Administration guidance.
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