Research Compliance
The Value of Continuity: Program-level DSMBs
Using a single DSMB for an entire therapeutic program ensures continuity of experience and offers potential cost savings and efficiency gains.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.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: 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.
Enhancing User Experience, Security, and Compliance with Single Sign-on
As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.
Navigating sIRB Complexities: An Interactive Session
Join us as we share insights, strategic priorities, and guidance for preparing your institution for sIRB mandates.
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.
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