 | IRB Initiation Procedures |
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| Client or Investigator Progress Reports |
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| Expedited Review |
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| Review the IRB Document List |
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| Submit an IRB Request Form |
Independent Institutional Review Board - Third Party Protocol Review
With institutional review of clinical research a virtual necessity for all human research, regardless of locale, Clinical R&D Services empaneled a high quality academically oriented Institutional Review Board in 1982. This board, composed of highly placed academic medical scientists and lay people, will review your research protocols. Submitted research projects and protocols will be reviewed in accordance with the highest current scientific and ethical considerations while strictly adhering to Food and Drug Administration regulations and procedures.
The IRB can also serve as a privacy board to handle Health Insurance Portability and Accountability Act (HIPAA) matters, either directly connected with a clinical trial as part of IRB review or separately as an entity unto itself. HIPAA issues, both as they apply to the conduct of trials or requests for exemption from certain HIPAA procedures, are routinely handled. The Boardıs decisions, based upon its deliberations, are all HIPAA compliant.BR>
Clinical R&D Services’ Institutional Review Board is the answer for practitioners who wish to conduct clinical research but must have access to an Institutional Review Board in order to proceed. This independent Institutional Review Board will also be of great value to the pharmaceutical industry in their search for highly qualified, rapidly and efficiently operating, reasonably priced institutional review.
This will be particularly advantageous for those single site studies and, especially, those multi-center clinical evaluations conducted outside the confines of hospitals and major medical centers. This board also provides the answer to the question of where to find an institutional review of those all important marketing studies both for prescription and non-prescription drugs, as well as medical devices, diagnostics and cosmetic products.
Our Institutional Review Board operates with strict adherence to the FDA regulations concerning institutional review. The board is constituted of those numbers, proportions and types of individuals as specified in the regulations. All of our practices and procedures meet and, in most cases, exceed FDA requirements. Both full panel IRB review and expedited review are available on a regular monthly basis. There is also a mechanism for requesting emergency and special unscheduled Institutional Review Board meetings.
Institutional review for any protocol is given for a period not to exceed one year on a fee for service basis. This fee will be reflected by the amount of material necessary for the board to review prior to its meeting. Expedited reviews are, of course, considerably less. Emergency meetings for institutional review can be convened at an additional cost. Our fees are quite reasonable and very competitive.
This board has been composed of a very representative group of individuals who are and have been involved in institutional review, clinical research and medical and legal ethics, so that the broadest, most rational approach to institutional review could be brought to bear upon research review within a most reasonable and efficient time frame at a very modest price.
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