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Phases of Clinical Research: A Detailed Overview
Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.
Read moreGood 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.
Developing a Data-driven Feasibility Process
Assessing feasibility in clinical research is vital for success, enabling organizations to make informed decisions and ensure seamless execution and reporting of studies.
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...
Strategic Training: Navigating Organizational Challenges
It’s important to define what falls into training and what doesn’t. The key is to know what the training is intended to accomplish.
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:
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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