Reporting Requirements
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.
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.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
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.
Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance
Monitor four critical metrics across your sites to prevent persistent challenges to clinical trials
Our OnCore CTMS Vision: Building a Foundation for Success
More than two decades ago, we created OnCore CTMS. What do we have in store for the future?
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.
Unpacking The Role of a Right-Sized QMS in Study Startup
Discover the crucial role of a customized QMS in streamlining and optimizing study startup processes.
GxP Compliance in Clinical Research
This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.