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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.
Impact of sIRB Mandates on Study Teams
Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
Interim Staffing: Reinvigorating Your Human Research Protections Program
Uphold research compliance best practices with an innovative approach to HRPP.
Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends
Dive into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
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.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
Trend Report: DE&I in Clinical Research: Where we are Today
How is the research community addressing recent regulatory actions urging improved diversity and representation in clinical trials?
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.
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