Consulting
Current State of Site-Sponsor-CRO Collaboration
View the Current State of Site-Sponsor-CRO Collaboration webinar to learn about survey findings, improve communication, and optimize clinical trial efficiency.
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.
Diversity, Equity, and Inclusion in Clinical Research
Achieving diversity, equity, and inclusion in clinical trials is vital for inclusive data, safe treatments, and addressing community-specific needs.
Budgeting for IRB Review: A Guide for HRPP Leadership
Internal IRB reviews are NOT free, contrary to popular belief. In this blog we outline practical steps for assessing and establishing IRB review cost
Preparing Your Action Plan for the FDA sIRB Mandate
Join our webinar for practical guidance from IRB thought leaders on what to include in your sIRB reliance preparations.
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.
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