Reporting Requirements
Adapting to the Evolving Era of Oncology: Implications and Strategies for Research Institutions
Explore key implications, regulatory challenges, and strategies for research institutions to thrive in today’s rapidly evolving oncology landscape.
The Evolution of Clinical Quality: Key Considerations from ICH E6 R3
Explore the key updates in ICH E6 R3 and their impact on clinical quality
From Simulation to Success: Stress Testing Your Inspection Readiness
Gain expert insights, best practices, and strategies to navigate FDA inspections with confidence.
Medicare Coverage Analysis in Oncology Trials
This webinar will cover the overall benefits of performing a Medicare coverage analysis, including important criteria to consider.
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.
4 KPIs Clinical Research Study Managers Can Master
This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.
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Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.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.
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