Reporting Requirements
Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing deviations in clinical research.
Best Practices for IRB Review of DCTs: Expert Perspectives
Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.
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.
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.
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.
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.
4 Modernized Functions Every Sponsor Needs for Study Startup
This white paper outlines four technology capabilities sponsors need to expedite the study startup process.
Navigating Key Complexities in the Development of Cell and Gene Therapies
Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.
Subscribe to our monthly email
Receive updates monthly about webinars for CEUs, white papers, podcasts, and more.
Advancing Clinical Research: Safer, Smarter, Faster™
Copyright © 2024 Advarra. All Rights Reserved.