Compliance Statement and FDA/OHRP Registration
Sabai IRB Services is registered with the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA).
IORG #: IORG0012659
IRB Registration #: IRB00014968
Compliance Statement
Sabai IRB provides IRB review services, working closely with clinical trial sponsors, contract research organizations (CROs), research foundations, sites, investigators, and institutions.
Sabai IRB is registered with the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) as IRB Organization #: IORG0012659, and IRB Registration #: IRB00014968.
Sabai IRB operates in compliance with applicable laws and regulations including, but not limited to, federal regulations at 45 CFR 46 and 21 CFR Parts 50 and 56, as well as other pertinent guidelines, such as the NIH Guidelines and the International Conference on Harmonisation (ICH) E6 – Good Clinical Practice, as applicable.
Striving to provide the highest quality in IRB review services, Sabai performs internal quality assurance reviews of its activities on a semiannual basis and routinely undergoes third party audits. Sabai’s IRB Services have Full Accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.), the gold standard for quality in research protections.
Questions or concerns may be directed to the Sabai team at 888-442-2472 or irbteam@sabaiglobal.com.
