CRO
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.
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).
IRB Review of Changes to Previously Approved Research
Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
Trend Report: DE&I in Clinical Research: Where we are Today
How is the research community addressing recent regulatory actions urging improved diversity and representation in clinical trials?
How Sponsors and Sites Work Together to Improve Protocol Compliance
As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.
Turbocharging Clinical Trial Activation Timelines
Understanding roadblocks to study activation and what your organization can do to mitigate them can ease study startup burdens.
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
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