Investigational Review Board Services
The Allendale Investigational Review Board of Regulatory and Technical Associates, Inc. provides clinical protocol review services to medical device and pharmaceutical companies, and to corporate and contract research laboratories throughout the world. Protocol review services for marketing surveys and focus groups are also provided. Investigational Review Board services are provided by a dedicated staff of IRB members with the necessary experience, knowledge, and credibility to scientifically and ethically execute their responsibilities in the protection of the rights and welfare of human research subjects.
The Allendale Investigational Review Board is a US Food and Drug Administration registered Investigational Review Board, which is duly constituted and compliant with FDA regulations, HEW and the Helsinki Agreement. The Food and Drug Administration periodically has conducted on-site audits of Allendale’s IRB services, and has consistently found us to be in compliance with all appropriate FDA regulations.
Reports of Investigational Review Board meetings are issued on the day of the meeting. Expedited clinical protocol reviews are conducted on an as need basis.
The Allendale IRB is led by Dr. Robert J. Staab as Chairman. Dr. Staab is Board Certified in toxicology and regulatory affairs by the American Board of Toxicology (DABT) and by the Regulatory Affairs Professional Society (RAC). He has served as the Chairman of both corporate and contract Investigational Review Boards for over 25 years.
The following information is required in order to schedule a clinical protocol review:
- The final protocol
- The cv of the Principal Investigator
- The Informed Consent document
- A product description (formula for device, drug, etc)
- All relevant safety data
- The Investigator Brochure, if relevant
- Recruitment documents, if any
- A description of special populations (special needs subjects, language barriers, etc.)
For more information regarding the Allendale Investigational Review Board, including items that must be listed on the Informed Consent form, please contact Dr. Robert J. Staab by phone (860-434-5872) or by email (rta1ali1@aol.com).