Regulatory Support — External Collaborations

Collaborating with external parties (universities, hospitals, etc.) have their own unique challenges that must be handled appropriately to ensure compliance with all applicable laws and regulations. Regulatory Affairs helps with determining what agreements, permissions, and procedures are needed to collaborate with external parties. Please see the FAQs below for more detail.

When should I get Regulatory Affairs involved?

Do I need a clinical trial agreement?

What is needed for receiving materials?

What is needed for sending materials?

What if I am only collaborating by conducting data analysis and/or helping with the manuscript?

What is needed with international collaboration?