New Advarra GxP AI tool, combined with expert-led GxP auditing services, helps sponsors, CROs, and sites proactively prepare for AI-driven regulatory audits
Columbia, Md. – March 18, 2026 – Advarra, the market leader in IRB oversight and a leading provider of connected, intelligence-powered research technology, today announced the launch of Advarra’s GxP AI tool. Part of Advarra’s GxP Compliance Intelligence solution, the app is designed to help sponsors, CROs, and sites continuously identify compliance gaps and strengthen quality management system (QMS) documentation.
“With AI-enabled tools like Elsa, regulators can now analyze entire QMS environments in hours,” said Abraham Seckler, managing director of GxP services at Advarra. “This is a dramatic shift from traditional inspections, in which less than 5% of available documents are reviewed over a several-day period. Gaps that once went undetected are now likely to be identified quickly and comprehensively. Advarra GxP Compliance Intelligence helps organizations modernize their compliance strategies by combining powerful AI technology with deep industry expertise to proactively identify potential gaps and vulnerabilities before regulators do. Once identified, our team helps close those gaps quickly and strategically.”
Advarra’s GxP AI app embeds AI-powered intelligence directly within a user’s QMS. The intuitive platform provides real-time visibility into compliance gaps benchmarked against global regulations and industry best practices, as well as early inspection risk signals across research facilities and vendors. Users can manage and remediate findings within the system, leveraging internal resources or Advarra’s quality experts for validation and tailored support.
The app is QMS-agnostic and integrates with existing environments—from enterprise platforms to simple SharePoint repositories—through secure, read-only API connections, requiring no document migration or workflow disruption. This nimble yet powerful offering allows organizations without centralized systems to securely upload documentation directly into the platform.
Unlike standalone tools, GxP Compliance Intelligence combines data intelligence with human-in-the-loop oversight from its global team of more than 1,000 consultants across six continents. Each year, Advarra completes more than 1,500 quality projects across 75 countries, supporting GxP-regulated environments including GMP, GCP, and GLP. The solution creates a comprehensive line of defense, detecting compliance risks before inspections disrupt development timelines.
Advarra’s GxP AI app is now available. To learn more, visit the GxP Compliance Intelligence page.
Media Contact:
Michelle Valentine
michellevalentinepr@outlook.com / mediarelations@advarra.com
About Advarra
Advarra provides the platform, insights, and expertise that make clinical trials more efficient and connected. As the leading independent IRB, we bring more than 40 years of trusted oversight to the industry, setting the standard for ethical reviews while building the largest collection of digitized protocols and operational data. This combined intelligence guides the protocol’s entire journey—from design through review, activation, and conduct—fueling a smarter, more adaptive research ecosystem.
Backed by decades of partnership with research sites, Advarra delivers the core systems and services that 50,000 investigators and their study teams depend on for optimal trial operations. Integrated with our solutions for study design, startup, and conduct, these capabilities create a collaborative technology platform trusted by sponsors and CROs globally.
By designing AI-powered workflows that streamline operations, reduce administrative burden, and promote transparency for all study stakeholders, we’re reimagining what’s possible in clinical research. Learn more at www.advarra.com.