Allendale Investigational Review Board of RTA Inc.
We offer clinical protocol review services to Research Organizations and Contract Laboratories throughout the world.
We have been audited by the US FDA for compliance with the regulations and have been found to be compliant in every way, i.e. no 483’s were issued.
We are experienced in IRB reviews since our combined years serving IRB’s approaches 50 years, as Chairman of 3 boards and as voting members.
AIRB has reviewed a diverse array of protocols for various ethical pharmaceuticals, innovative skin protectant products, analgesics, surgical drapes, antimicrobials, spinal electrodes, feminine hygiene products and genetically engineered tomatoes to innovative contraceptive devices. We have served such companies as J&J, Bristol-Myers, Kimberly-Clark, Smith Kline Beacham, American Home Products, Sharplan Lasers, Medtronic, London International Group, Unilever, Warner Lambert, Pfizer, and several contract clinical facilities. We have reviewed protocols for drugs, medical devices, foods, nutritionals, consumer products and cosmetics as well as psychological questionnaires whether they be required by law or to assure independent review of a key protocol. Our reviews have complied with regulations from FDA, EPA, CPSC and foreign bodies.
As Chairman, I am board certified in Regulatory Affairs, as well as Toxicology, and in a good position to keep abreast of the regulations concerning IRB’s from the FDA, CPSC, EPA as well as those of the NIH /FDA (IRB Registration # IRB00004889).IORG0004889 represents the overall registration, with each IRB receiving a distinct identification number under the IORG. The following IRB(s) are registered with the Office for Human Research Protections (OHRP): IRB00005829 Allendale Investigational Review Board IRB #1(re-registration due 12/15/12)
The combined experience of representatives of the nursing, medical, ministerial, counseling, and toxicology professions as well as non-medical or research oriented personnel gives us unique insight into the review of clinical research and represents several cross sections of our society.
We are particularly proud of our timely review and reports to the sponsor; we will do our professional best to respond. Although we meet at the sponsor’s request, due to the demand for our service, we meet practically every week. If you would like to discuss how the Allendale IRB could be of service to your organization, please call at your convenience.