Institutions
The Importance of Strategic Planning for Long-term Training Success
Discover strategic planning for software training and learn to align efforts with future needs for long-term business success.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.
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.
sIRB Review for Multicenter Research: A Guide for Institutions
Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...
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.
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.
Optimizing Site Initiation Timelines Through Centralized Processes
Learn how to optimize clinical trial initiation with centralized processes, intuitive intake forms, and custom reporting and streamline workflows for efficiency.
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