What Is ALCOA+? A Practical Guide for Clinical Research
Clinical research decisions are only as sound as the records supporting them, and that soundness begins with data integrity: the
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What Is the Difference Between Monitoring and Auditing in Clinical Trials And Why Do They Matter for Inspection Readiness?
Clinical trial monitoring (CTM) and auditing are both essential quality management activities, but they serve distinct purposes throughout the research
21 CFR Part 11 and Good Clinical Practice Requirements Explained
Clinical research increasingly depends on electronic systems to support core trial documentation, data handling, and regulated workflows. That shift has
Insights on the FDA’s ELSA AI And What Changes Next
Traditional clinical trial designs often delay progress due to rigid protocols and frequent amendments. Adaptive and platform trial models introduce flexibility and shared infrastructure, reducing startup delays, cutting costs, and enabling sponsors to conduct faster, more efficient research.
Preparing for Elsa: What Sponsors, Sites, and CROs Need to Know About the FDA’s New AI Era
Traditional clinical trial designs often delay progress due to rigid protocols and frequent amendments. Adaptive and platform trial models introduce flexibility and shared infrastructure, reducing startup delays, cutting costs, and enabling sponsors to conduct faster, more efficient research.
The Impact of ICH E6(R3) on U.S. and Canadian IRBs
Now that FDA has published the ICH E6(R3) Good Clinical Practice (GCP) guidance, aligning early with these requirements can prepare organizations for the future. ICH E6(R3) encourages ethics review committees to more intelligently apply their resources by enhancing efficiency without compromising participant safety or data integrity particularly regarding continuing review, informed consent, decentralized logistics, and data governance. Sponsors partnering with Advarra can be confident that their studies remain regulation-ready on both sides of the border today and E6(R3)-ready for tomorrow.
Are you prepared for ICH E6 (R3)?
The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.
ICH E6(R3) Implementation Starts Now: Are You Ready?
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
The Evolution of Clinical Quality: Key Considerations from ICH E6 R3
The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of
GxP Best Practices for Safer, Smarter, Faster Clinical Research
GxP guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.
Vendor Qualification vs Requalification Audits: What’s the Difference?
Different types of audits can be performed to support your vendor qualification and management program. These audits should be conducted using a risk-based approach. In this blog, we outline the difference between these types of audits and how to identify vendors that have the most potential risk for your program.