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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.

Assessing feasibility in clinical research is vital for success, enabling organizations to make informed decisions and ensure seamless execution and reporting of studies.

This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.

A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.

Explore key local considerations for developing single IRB policies, and learn how to navigate the challenges- including compliance, ethical standards, and institutional requirements.

Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.

May 16, 2024

Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...

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.

Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:

Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.

Uphold research compliance best practices with an innovative approach to HRPP.

Using a single Data Safety Monitoring Board for an entire therapeutic program ensures continuity and offers cost savings and efficiency gains.