Sabai IRB Services

Sabai Institutional Review Board (IRB) Services consist of two premier institutional review boards whose mission is to protect the rights, safety and welfare of human research participants who participate in research studies.

FDA/OHRP Registration
Alpha IRB Oasis Portal
Castle IRB Portal
Resources
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Castle IRB and Alpha IRB have partnered to provide exemplary client support to researchers for all phases of research; along with Quality, Timeliness and Subject Matter Expertise.

Both Institutional Review Boards are currently operating independently with separate AAHRPP accreditations and OHRP/FDA registrations.  Both IRBs have specialty areas of IRB review and our team can help you decide the best option for your project.

Our IRBs both utilize an IRB Manager Web Portal system. Key features include:

  • Ability to track the progress of a study or site submission through IRB review process
  • All study documents (and site submissions) can be submitted online and are available 24/7
  • Copy feature for quicker submission next time

IRB Services Include:

Sabai IRB Services follows US DHHS and FDA Regulations, the Belmont Report, ICH GCP and NIH Guidelines as well as local/state laws.

  • Multi-site and Single Site/Investigator studies in pharma, device/human factors, biotech, social-behavioral, natural history, registry and investigator-initiated projects
  • Single Patient Expanded Access/Compassionate Use
  • Exempt Determination reviews
  • Initial Review, Continuing Review of Research, On-Going reviews, including Amendments and Safety Reporting
  • Determinations of what is/is not research requiring IRB review
  • Informed Consent Form Pre-Review/Consultation and development
  • Translation Services
  • Generic Materials
WHAT SETS US APART

What Our Clients Say

"Christine was very patient with our questions and did a great job explaining and helping the site learn—[made] the process incredibly seamless and we look forward to our next project together."

Dakota Gaines CenExel

"Many thanks for your excellent service. [You’ve] been the easiest and most collaborative and communicative IRB to work with. Hoping to cross paths again!"

Gina Gorgone Simone Sr. Project Leader, Emmes

"The best vendor I have ever worked with."

Associate Director of Clinical Operations Merck

"We love you guys."

Research Safety Associate Director over Biosafety University of California-San Diego

"Accelerated our timelines and beat our projections for our sponsor, with the added complexity of IBC on top of IRB regulatory."

Study Start-Up Director MedPace CRO

"Every time I interact with your team I walk away with a smile. For Shield, Heidi has been my lifesaver: pragmatic, understanding, and action-oriented. I have come to her feeling overwhelmed and unsure of how to tackle complex issues, and within the span of a single call she develops a plan and I am able to walk away with 1000 pounds lifted off my shoulder."

BSO Pharmaceutical Company

Contact Sabai

For prospective and current participants, sponsors/CROs, researchers or others who wish to discuss problems, concerns, questions, or who wish to obtain information, or offer input about each IRB, please contact us at:

ALPHA IRB

1001 Avenida Pico, Suite C, #497, San Clemente, CA 92673

949-542-3882
Fax: 949-940-0134
[email protected]

CASTLE IRB

16150 Main Circle Drive, Suite 100, Chesterfield, MO 63017

1-888-442-2472
[email protected]

companies and concerns

Any person with concerns regarding the conduct of Sabai is encouraged to contact officials through the following means:

1-888-442-2472
Contact Sabai

www.lighthouseservices.com
Contact the Compliance Hotline

833-370-0002
Toll-free English speaking

800-216-1288
Toll-free Spanish speaking