Updated IRB Handbook Available
Advarra’s IRB Handbook Advarra has updated its Institutional Review Board (IRB) Handbook for Investigators,...
2026 Trend Report
Reducing Avoidable Protocol Amendments by Anticipating Operational Pitfalls Hidden in Clinical Trial Design
Protocol amendments are a costly but common part of clinical trials, often reflecting gaps between scientific ambition and real-world execution.
News
Advarra’s Study Design Solution Named “Best Clinical Study Design Solution” in 2026 MedTech Breakthrough Awards Program
Landmark 10th annual awards program, which received over 5,000 entries, recognizes the most innovative digital health and medical technology solutions worldwide COLUMBIA, Md., – May 7,...
Emerging Use of Bacteriophages, Natural Predators of Bacteria, to Combat Antibiotic Resistance in the Clinic and Beyond: A Review of the Field and Biosafety Assessment
Explore the latest research on bacteriophage therapy, including advances in clinical development, biosafety, and...
New Framework Proposes Risk-Based Governance for AI in Clinical Development
Estimated reading time: 4 minutes First deliverable from the Council for Responsible Use of...
Blogs
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...
Advarra AI Council Members Participate in a Panel at Northwestern University to Discuss the Impacts of AI on Biosecurity
What impact will advancements in artificial intelligence (AI) have on national security and global...
The Data Monitoring Committee Charter Is Now a Strategic Governance Document
FDA’s 2024 draft guidance signals broader expectations for data monitoring committee (DMC) independence, communication, documentation, and sponsor decision-making. For...
Why IRBs Ask for Certified Translations of Informed Consent Forms: Regulation, Guidance, and Practical Reality
Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards...
Webinars
Meeting Sites Where They Are: A Connected, Intelligence-Powered Operating Model
Meeting Sites Where They Are: A Connected, Intelligence-Powered Operating Model This on-demand webinar, presented...
Ensuring Operational Feasibility in Next-Generation Oncology Trials
Our webinar discusses key near-term trends and regulations and investigate persistent challenges frequently throwing...
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...
Enabling Oncology Site Success: Overcoming Administrative and Operational Barriers to Advance Cancer Research
Enabling Oncology Site Success: Overcoming Administrative and Operational Barriers to Advance Cancer Research Oncology...