The U.S. Food and Drug Administration’s (FDA’s) recent draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory The post Advarra’s Perspective on FDA’s Draft AI Guidance: Advancing Responsible Innovation first appeared on Advarra.| Advarra
Advarra partnered with PreHealth, a brand growth and experience agency, to create Braid, the identity for Advarra’s data and AI engine. To share the story behind the name and brand, we spoke with Laurie Thackeray, Head of Global Marketing at Advarra, and Mike Hartman, Founder and CEO of PreHealth. Here’s what they had to say| Advarra - Advancing Better Research
Read the best thought leadership in the clinical research industry from the experts at Advarra| Advarra - Advancing Better Research
Advance human health with our global team. Join us to make clinical research safer, smarter, and faster, delivering life-changing therapies worldwide.| Advarra - Advancing Better Research
CONSULTINGGxP Services From early discovery to managing your global portfolio, address all your GxP compliance needs and concerns with Advarra, wherever you are in the development journey. GxP Info Sheet Your Trusted and Proven Partner for Global GxP Quality Compliance Rely on Advarra to establish, plan, review, or correct any GxP quality requirements for your| Advarra - Advancing Better Research
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.| Advarra - Advancing Better Research
Advarra advances clinical research with expert review services, cutting-edge technology, and consulting. We streamline compliance and accelerate trials.| Advarra - Advancing Better Research
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.| Advarra - Advancing Better Research
ICH E6(R3) is here—are you ready? Learn how this major GCP update reshapes clinical trial oversight with risk-based proportionality, quality by design, and regulatory alignment. Discover key actions sponsors must take now.| Advarra - Advancing Better Research
Have questions about Advarra? Whether you're looking for streamlined processes, expert guidance, or advanced technology, our team is here to help.| Advarra - Advancing Better Research
We recently welcomed Jan Hewett as our senior vice president, FDA regulatory advisor. With a decade of experience as regulatory counsel in the FDA’s Center for Drug Evaluation and Research – Office of Scientific Investigations, her experience will help Advarra’s clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research.| Advarra - Advancing Better Research
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies. The post The Value of Clinical Research first appeared on Advarra.| Advarra
Advarra's commitment to ethical clinical research for over 35 years drives medical breakthroughs, ensuring participant safety and enhancing treatment options. The post Advancing and Safeguarding Clinical Research for a Better Tomorrow first appeared on Advarra.| Advarra
Launched in January 2025, the Association of Multisite Research Corporations (AMRC) was set up by its founding members to advance The post An Interview with Jim Kremidas: What’s Next for the Association of Multisite Research Corporations (AMRC) first appeared on Advarra.| Advarra
The beginning of a new semester brings a fresh crop of aspiring researchers to institutions each fall and spring. Students The post Help for HRPPs: Educating the New Researcher community on SBER Basics first appeared on Advarra.| Advarra
Get resources and best practices for clinical research site, sponsor, and CRO relationships including transparency, feasibility, and more.| Advarra
Get resources and best practices for clinical research financial management including coverage analysis and participant payments.| Advarra
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.| Advarra
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.| Advarra
Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:| Advarra
Get resources and best practices for clinical research reporting requirements including common rule, FWA, ALCOA, and more.| Advarra
Get resources and best practices for clinical research operations including site management, workflows, community engagement, and more.| Advarra
Get resources and best practices for clinical research compliance including 21 CFR Part 11, regulatory management, FWA, and more.| Advarra
Learn how Longboat is reimagining critical workflows across sites, sponsors, CROs, and patients.| Advarra
Internal IRB reviews are NOT free, contrary to popular belief. In this blog we outline practical steps for assessing and establishing IRB review cost| Advarra
Find out how the EU AI Act will likely impact clinical research software and systems, and what EU and non-EU entities should do to prepare for compliance.| Advarra
Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.| Advarra
Assessing feasibility in clinical research is vital for success, enabling organizations to make informed decisions and ensure seamless execution and reporting of studies.| Advarra
This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.| Advarra
A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.| Advarra
Explore key local considerations for developing single IRB policies, and learn how to navigate the challenges- including compliance, ethical standards, and institutional requirements.| Advarra
Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.| Advarra
Advarra leverages exceptional client service, innovative technology and robust global regulatory expertise. Check out our blog for more industry insights.| Advarra
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.| Advarra - Advancing Better Research
The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.| Advarra - Advancing Better Research
