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
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Indiana University Melvin and Bren Simon Cancer Center Sees 52% Time Savings With Advarra Participant Payments
Indiana University Melvin and Bren Simon Cancer Center, Indiana’s only NCI-designated cancer center providing patient care, conducts more than 600
A More Connected Approach to Clinical Trials: Reducing Friction from Study Design Through Conduct
Clinical trials are complex. That’s expected, given accelerated advancements in science and technology. But when that complexity creates friction in
Top 20 Pharma Exceeds Recruitment Targets and Reduces Screen Failures Across 188 Sites
A top-20 pharmaceutical company was conducting a Phase III breast cancer study in 16 countries across North America, Europe, and
Top 20 pharma accelerates training and enrollment across 650 Site Staff
A top-20 pharmaceutical company was planning a large Phase III trial of a new vaccine for a mosquitoborne viral disease.
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.
Clinical Trial Budget Negotiations: A View From Each Side
Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.
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.
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GxP Compliance Intelligence Global GxP Experts, Smarter with AI From early discovery to managing a global development portfolio, our industry-leading
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.