Optimum Ethics Review Board (ERB) is an independent ethics review board (also called an IRB or REB) that is constituted and operates according to Division 5 of the Food and Drug Regulations,  ICH/GCP Guidelines, FDA 21 CFR Parts 50 & 56, DHHS Section 45 CFR 46, the Declaration of Helsinki, FDA Information Sheets: Guidance for IRBs and Clinical Investigators and the Tri-Council Policy Statement for Ethical Conduct of Research Involving Humans.

It was formed in September 1995, to respond to the needs of investigators and the pharmaceutical industry.  It is comprised of members with diverse and varying backgrounds in the medical, physical and social sciences.

Optimum Ethics Review Board Offers:
              
• Quality Ethics Review...in a timely manner
• Weekly Meetings/Flexible Scheduling  
• Experienced Members and Staff
• Prompt Responses/Turn around time
• Proper Documentation
• Single-centre or Multi-centre Review
• Customized Documentation Forwarding
• Site Assistance
• Continuing Review
• ICH-GCP Compliance

 

Please note: Some of the documents/instructions included on this website may not pertain to BA/BE Studies. Please email us with your contact information if you prefer to discuss by phone.