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Good Manufacturing Practices: When Do They Apply?
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.
Conducting Research With CAR T Cells
This white paper is a guide for research professionals looking to conduct CAR T cell studies for the first time, as well as for those seeking to expand their existing portfolio.
Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites
This eBook provides a toolkit to understand the institutional review board's role when sIRB review is utilized.
GxP Audits Guide for Successful Clinical Trials
Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends
Dive into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Inside Study Activation: Budgeting Takeaways
Learn how sites, sponsors, and CROs can work together to help study activation, specifically within budgeting and contracting.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
Striking the Balance: Ethics, Inclusion, and Vulnerability in Research
Explore the ethical tensions between including under-represented communities and ensuring vulnerable participant populations are appropriately protected.
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