Reporting Requirements
Good Manufacturing Practices: When Do They Apply?
Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.
Conducting Research With CAR T Cells
This white paper is a guide for research professionals looking to conduct CAR T cell studies for the first time, as well as for those seeking to expand their existing portfolio.
Navigating Local Considerations When Developing sIRB Reliance Policies
Explore key local considerations for developing single IRB policies, and learn how to navigate the challenges- including compliance, ethical standards, and institutional requirements.
GxP Audits Guide for Successful Clinical Trials
Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.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.
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