Regulatory Services

Navigating the Regulatory Framework of Clinical Research

Regulatory coordinators provide support for both industry sponsored and investigator-initiated clinical trials
for review of Institutional Review Board (IRB), Food and Drug Administration (FDA), and other compliance
submissions, ensuring completeness of requirements and inclusion of all required documentation.

Our regulatory coordinators support the Principal Investigator by facilitating and coordinating protocol activities including:

• Prepare and submit IRB applications (initial, continuing review, amendments)
• Prepare and submit for institutional approvals
• Protocol development – assist drafting investigator-initiated protocols
• Develop, draft, and edit study forms and materials
• Ensure compliance with federal and state regulations and institutional recommendations/guidance
• Review written study procedures and draft data collection forms
• Create and maintain regulatory binders to meet sponsor and federal regulatory requirements
• Ensure compliance with ICH E6 Good Clinical Practice and Code of Federal Regulations requirements