New Paper Makes the Case for AI-Specific Guidance in Research Oversight
AI is becoming a routine part of how research proposals are prepared and reviewed, from drafting applications to supporting administrative
Awareness
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.
Embedding AI And Critical IRB Operations Data To Drive Intelligent Study Design
Our webinar discusses key near-term trends and regulations and investigate persistent challenges frequently throwing even the most efficient teams off track. Advarra and industry representatives will dive deeper into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
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.
Simplifying Oversight and Managing Regulatory Complexity in Multi-Site Clinical Trials
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.
How to Select a Clinical Trial Management System
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.
Integrating AI to Balance Scientific Rigor and Real-World Feasibility in Clinical Trial Study Design
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.
How Sponsors Can Use Adaptive and Platform Trial Models to Reduce Amendments and Accelerate Study Start-Up
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.
Q&A with Advarra’s Associate Director of Client Services Anna Carnevale
Over the past 14 years, Anna Carnevale, associate director of client services at Advarra, has seen her team grow from
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.
Advarra’s Perspective on FDA’s Draft AI Guidance: Advancing Responsible Innovation
The U.S. Food and Drug Administration’s (FDA’s) recent draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory
The Story Behind Braid: How the Brand Reflects Advarra’s Vision for Data and AI in Clinical Research
Advarra partnered with PreHealth, a brand growth and experience agency, to create Braid, the identity for Advarra’s data and AI