Sabai IRB

Alpha IRB and Castle IRB are Merging to Form Sabai IRB,
a Premier Independent Institutional Review Board for Research.

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Merger FAQ  |  Vendor Registration  |  Contracts  |  Billing & Finance  |  Regulatory & Compliance  |  Portal Systems & Submissions  |  ICFs

Alpha IRB and Castle IRB, two highly respected independent institutional review boards (IRBs), will complete their merger in February to form Sabai IRB, establishing a premier IRB committed to advancing the ethical review and oversight of research. The newly formed organization combines decades of experience in regulatory compliance, human subject protections and efficient IRB operations to better serve the evolving needs of the research community.

“Sabai provides ethical and biosafety review and support that leads with science and differentiates with service. With a strong history from both Alpha IRB and Castle IRB, we maintain a people-first culture and a deep commitment to taking care of our clients—values reflected in Sabai’s very name. We are the “smart choice” based on our years of experience, extensive knowledge and credentialing.”

– Mike Keens, Sabai CEO

With this merger, we're excited to offer:

  • Simplified forms and a streamlined user experience
  • More frequent IRB meetings for faster IRB review
  • A larger team with diverse expertise
  • Expansive regulatory and therapeutic expertise
  • A single, enhanced IRB Portal

The newly merged IRB will operate under the Sabai name, with a national presence serving research sponsors and institutions across the United States. Clients of Alpha IRB and Castle IRB can expect a seamless transition, with the same dedicated staff, service excellence and regulatory expertise they have relied on.

If you have questions regarding IRB Integration, please contact clientservices@sabaiglobal.com

Sabai IRB Merger FAQ

1. How should I refer to Alpha IRB & Castle IRB?
  • We love our new name and encourage you to begin referring to us as Sabai! That said, approval letters, 1572s, and IRB registrations will continue to reflect our legacy Alpha IRB and Castle IRB names until our merger is complete, so they will be with us for a bit longer.
2. When will the merger of Alpha IRB and Castle IRB occur?
  • The merger is in process and is expected to be completed by the end of February 2026.  Once the merger is complete, both IRBs will be operating under the legal name Sabai, LLC and will be using “Sabai IRB” on all study related materials.
3. What is Sabai’s legal structure?
  • Sabai, LLC is a Missouri corporation with headquarters located at 16150 Main Circle Drive, Suite 100, Chesterfield, MO 63017.

Vendor Registration

1. Should my company update its vendor registration portal to reflect the Sabai name and EIN?
  • This is a company specific decision, but to avoid confusion we’d ask that legacy Alpha or Castle names be updated to the Sabai name. We are available to support that process administratively, simply reach out to finance@sabaiglobal.com if you require any specific documentation.
2. My company needs to re-qualify Sabai as a vendor to ensure no gaps in services, invoice payment, etc. Who can I contact?

Contracts

1. If my company has an existing contract with either Alpha or Castle IRB legal entities, does my company need to sign a new contract with the Sabai entity?
  • In most cases, no. Existing contracts will be formally assigned from the legacy entities to the Sabai legal entity through a notice of assignment. This process transfers all rights and obligations without requiring you to re-execute agreements. You will receive written confirmation once the assignment is complete. In cases where contracts would need to be re-executed, you will receive a specific request indicating as such.
2. After contract assignment, what name will appear on invoices and payment instructions going forward?
  • Invoices will be issued by the Sabai entity. Payment instructions—such as remit-to name, bank account details, and EIN—will be clearly identified on the invoice. Please update your accounts payable records accordingly once notified.
3.  Do I need to update my IRB reliance agreement?
  • All clients with active reliance agreements (previously with Castle IRB and Alpha IRB) have been notified and provided a Memo to File regarding our updated Sabai IRB name and registration. This Memo can be filed to show documentation of the updated IRB name and registration. 
  • If for any reason your institution would prefer to enter into a new reliance agreement, please reach out to Client Services at clientservices@sabaiglobal.com. Sabai IRB is part of the SMART IRB reliance initiative, and we are happy to use the SMART IRB Letter of Acknowledgement, the Sabai IRB template reliance agreement or review your institution-specific agreement, if needed. 

Billing and Finance

1. When will this integration impact how my company coordinates with Finance?
  • The operational integration to Sabai is underway, with formal administrative notices distributed to customers in Q4 2025 and into early 2026. These notices will include formal contract assignment from the legacy IRB entities to the new Sabai entity.
2. Will this change affect the legal entity or tax identification number (EIN) associated with my company’s agreement?
  • Yes. The two legacy IRBs previously operated under separate legal entities, each with their own Employer Identification Number (EIN). Going forward, all IRB operations and customer contracts will be associated with a single, Sabai legal entity with a different EIN.
3. Where should payments be sent during the contract assignment process?
  • Until you receive the contract assignment notice, please continue submitting payments using your current instructions and invoice instructions. Once assigned to the Sabai entity, payments should be directed to the new entity’s banking and remittance details, which will be included on updated invoices.
4. My company requires an updated W-9 for the new Sabai entity for its records, where can I obtain it?
  • W-9’s will be distributed with the formal contract assignment notices. Requests for copies of the new Sabai W-9 can be made to finance@sabaiglobal.com.
5. Who can I contact for Finance, Invoice or Payment related questions?

Regulatory and Compliance Considerations

  • 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.
  • Sabai IRB is working with AAHRPP to maintain continuous accreditation through the transition and merger, with the existing accreditation statuses of legacy Alpha and Castle IRB serving as the foundation for the merged entity.
  • Both Legacy Alpha and Castle IRB previously operated under Sabai’s centralized QMS policies and SOPs. The Quality department continues to function under Sabai, LLC’s administration division, using ZenQMS, a validated system compliant with ISO 9001:2015 and 21 CFR Part 11.
1. Do we need to update our Federalwide Assurance (FWA)?
  • If your institution designated Castle IRB as the only IRB on your FWA, or if Castle IRB reviews the largest percentage of research covered by your FWA, an update to list Sabai IRB is needed.
  • If your institution designated Alpha IRB as the only IRB on your FWA, or if Alpha IRB reviews the largest percentage of research covered by your FWA, an update to list Sabai IRB is needed.
2. What are the FWA, IORG and IRB Registration numbers for Sabai IRB?
IORG #: IORG0012659
IRB Registration #: IRB00014968
  • FWAs are required of institutions that conduct human subjects’ research. Sabai IRB does not conduct research, thus does not maintain an FWA. The IORG registration serves in place of the FWA.
3. How should sponsors handle IND/IDE notifications due to the new IORG number?
  • Since Sabai IRB is operating under a new IORG registration, sponsors should update FDA or device regulatory files to reflect the transfer of IRB oversight. This can be done through:
  1. An IND Information Amendment (or Protocol Amendment, if tied to a specific protocol change), or
  2. An IDE Annual Report or Supplement.
  3. A new Form FDA 1572 is not required solely due to this administrative IRB transition.

Sample IND Amendment Language for Sponsors (To copy into IND update or annual report)

IND [number] – Information Amendment
Subject: Update of IRB Oversight – New IORG Registration

Oversight of clinical studies conducted under IND [number] has transitioned to Sabai IRB (IORG#: IORG0012659, IRB#: IRB00014968).  This transition consolidates prior IRB oversight from Alpha IRB (IORG#: IORG0005158, IRB#: IRB00006205) and/or Castle IRB (IORG#: IORG0010151, IRB#: IRB00012054).

This administrative change does not affect:

  • Approved study protocols,
  • Investigator responsibilities, or
  • Human subject protections.

Existing 1572s do not need to be updated per item #7 of this FDA Guidance: Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions Statement of Investigator (Form FDA 1572).

  1. Investigators should document the change in clinical study records and inform the sponsor. See the Sabai IRB Memo to File for your study records.
  2. Sponsors can submit this information to the IND along with other updates, such as an information amendment or a protocol amendment.
  3. The 1572 itself does not need to be revised, and a new 1572 does not need to be signed by the investigator.
Date Acceptable 1572 Entities
Prior to February 2026 Castle IRB Castle IRB 16150 Main Circle Drive, Suite 100 Chesterfield, MO 63017
Prior to February 2026 Alpha IRB Alpha IRB 1001 Avenida Pico, Suite C #497 San Clemente, CA 92673
February 2026 onward Sabai IRB (formerly Castle IRB or Alpha IRB) Sabai, LLC 16150 Main Circle Drive, Suite 100 Chesterfield, MO 63017
4. How should study teams document the IRB name change for regulatory compliance purposes?
  • Written communication about the IRB name change will be issued to clients. The communication may be filed within site regulatory binders, attached to IRB approval letters, or included in continuing review submissions to demonstrate continuous oversight and regulatory traceability.
5. How are regulatory documents such as SOPs and policies being harmonized?
  • Sabai IRB operates under the Sabai, LLC Quality Management System, integrating best practices from both legacy IRBs. All governing policies, SOPs, and templates are being updated primarily to reflect the Sabai IRB name and harmonize minor procedural differences while maintaining equivalency with previously accredited systems.
6. How will clients be notified of future compliance or significant policy updates?
  • Clients will receive written notification of material policy or procedural changes through the Client Services team. Updated policies will be available upon request for audit or regulatory submission purposes.

Portal Systems and Submissions

  • Sabai IRB will use the same a single portal system with more simplified forms.
  • For Castle clients, the portal location will not change and current accounts will remain active. Alpha clients will migrate to the new location at https://review.sabaiglobal.com and will register using the instructions in this pdf.
  • Additional training and support will be provided to ensure a smooth transition. Please reach out to Client Services at clientservices@sabaiglobal.com if you need additional assistance.
  • We are excited to share that our new streamlined forms will be available on February 2nd, 2026.
  • Studies will be routed to the same IRBs for consistency and continuity in review.
  • We do not anticipate any delays to your portal submissions.
1. Will existing study materials and documents be transferred to the Sabai IRB portal?
  • Yes. OneAegis (IRBManager) remains the system of record. Sabai IRB will retain all transferred study records (e.g., protocols, prior approvals, minutes, UAP/AE reports, and correspondence) for a minimum of three years after study completion, or longer if specified by contract. All legacy Alpha IRB study records (active and closed) will be securely migrated to the Sabai IRB portal. Access controls, audit trails, and data integrity will continue to meet 21 CFR Part 11 requirements. Legacy Castle IRB clients will remain in their existing portal environment, while Alpha IRB clients will be notified when access to the new portal is established. Both portals operate within the same validated OneAegis (IRBManager) platform; no significant changes are expected to the user interface or experience.
2. Will any study documentation or archived materials be lost during legacy Alpha IRB migration?
  • Forms will be preserved and accessible via PDF in the new portal. The retired portal will remain accessible by Sabai use only for redundancy. Both legacy systems operate within the same secure OneAegis environment.
3. What if I have an online form/application in progress that is nearly ready for submission?
  • No need to worry!  If you have an IRB application already in progress at the time of our transition, we will accept your submission.  Should our team identify any missing or unclear information, we will contact you directly to collect the necessary details to proceed with IRB review.

Attention Legacy Alpha Clients:

  • To enable a smooth transition for our legacy Alpha clients, we will be closing the Oasis portal for any new submissions starting on January 30th , 2026 at 5 p.m. EST.
  • If you anticipate that you need to make a submission for an Existing/Active study (including a new investigator on a study) between January 31st – February 8th, please contact us at sites-alpha@sabaiglobal.com and we will provide guidance on the best method of submission.
  • If you are submitting a new protocol for review the week of February 2nd you will submit using the new MySabai portal at https://review.sabaiglobal.com
  • Beginning February 9th, all submissions can be made using the new MySabai portal at https://review.sabaiglobal.com
4. Are there any changes to Continuing Review Timelines?
  • No, the original Legacy IRB anniversary date is maintained unless a review at transfer establishes a new (≤ 1 year) date.
5. When is the transfer of oversight effective?
  • Transfer of Oversight will begin on February 2nd, 2026.
  • Legacy Castle Clients: Transfer of oversight will be effective on February 2nd, 2026.
  • Legacy Alpha Clients: For any submissions in progress at the time of this transition, legacy IRB approvals will govern and will complete under the legacy Alpha IRB branding. Once all “in progress” items for a given study are completed, the study and all associated documentation will be fully transferred to Sabai IRB.
  • The Sabai IRB team anticipates that all legacy Alpha IRB studies should be fully transitioned to Sabai IRB by the end of February 2026.

Informed Consent Forms

1. ICFs issued in February will reference the IRB in the following ways:
  • Legacy Castle IRB: for ICFs released prior to February 2nd, Castle IRB will be listed. Any ICFs released starting February 2nd will list Sabai IRB.
  • Legacy Alpha IRB: for any submissions completed in the Alpha Oasis portal, the Alpha IRB name will be listed. Any submissions made or completed through the MySabai portal will list Sabai IRB.
Submission Type ICF Impact
New Studies ICF will reference Sabai IRB
New Sites ICF will reference Sabai IRB
New PI/Changes to PI ICF will reference Sabai IRB
Response to Contingencies ICF will reference Sabai IRB
Amendments with ICF Changes ICF will reference Sabai IRB only for the ICFs impacted by the amendment. The legacy IRB references will remain for all other ICFs not impacted by the amendment.
Amendments without ICF Changes Legacy IRB reference will remain until next impacted submission type.
Continuing Reviews Legacy IRB reference will remain until next impacted submission type.
2. Will use of contact information listed in existing ICFs reach Sabai IRB?
  • Yes. Participants who use contact information, such as phone number and email addresses in existing (legacy Castle IRB or Alpha IRB) ICFs will be forwarded to Sabai IRB for the foreseeable future. 
3. How can participants be notified of new IRB name/contact information before our ICF is updated?
  • Sabai IRB will issue a Participant Letter that can be provided to active study participants in this scenario. This will be located in the MySabai portal in the left menu, Useful Links section (this will be available on February 2nd, 2026). Use is optional as contact information in existing ICFs will continue to reach Sabai IRB.
4. Are we required to reconsent participants due to the change in IRB name and contact information?
  • No, Sabai IRB does not require reconsent solely due to updated IRB name and contact information. Reconsent may be required due to other changes being made at the time IRB information is being updated.
5. Will there be changes to the approval version or format of ICFs for Sabai IRB?
  • Yes. Sabai IRB will issue approved ICFs with specific IRB versioning, in a Protected Microsoft Word format without a corresponding PDF. For more information about Sabai IRB ICFs, including versioning, formatting, creating site ICFs for multi-site studies, and how to revise ICFs, see the Sabai IRB Informed Consent Guidance. Related compliance information is available in a Sabai IRB Memo to File.

If you have questions regarding IRB Integration, please contact clientservices@sabaiglobal.com