Sponsors
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Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.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.
SAE Reporting and the IRB: Adverse Events in Drug Studies
Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.
Checklist to Reduce Burden on Sites and Patients
Review a list of considerations for site-sponsor tasks to streamline startup, reduce redundancy, and refine technology choices for effective partnerships.
DSMB Best Practices and Behind the Scenes Insights
Enhance clinical trial oversight with expert insights on member selection, bias elimination, and regulatory compliance from 20+ years of leadership experience.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
Faster Trials, Successful Sites, Empowered Patients: Improve Your Research Experience
Optimize clinical trials with practical solutions, real site feedback, and tools for seamless success. Join our webinar to revolutionize your research approach.
How to Improve Your Site Compliance
Many clinical trial sites face challenges to stay compliant on a study. It is important for sites to adhere to the myriad of requirements that constitute Good Clinical Practices (GCP).
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