Research Compliance
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.
Business Best Practices for Research Sites
Explore key process and technology focus areas for sites looking to improve their business strategies.
The Regulatory Binder Checklist For Clinical Trial Sites
This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.
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.
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...
Planning for Complex Change at Your Organization
Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Uphold research compliance best practices with an innovative approach to HRPP.
The Value of Continuity: Program-level Data Safety Monitoring Boards
Using a single Data Safety Monitoring Board for an entire therapeutic program ensures continuity and offers cost savings and efficiency gains.
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