iMedRIS/Integrated Research Information System (iRIS) Software/Maintenance Renewal VA-26-00065187

SOLE SOURCE JUSTIFICATION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. This requirement will be accomplished via:

[X] New Purchase Order

[ ] Modification No.

[ ] Purchase Card

Purchase Order will be:

[X] Firm Fixed Price [ ] Cost Type Contract:

[ ] Time and Materials [ ] Other (Specify):

Type of Funds (e.g., Supply Fund, Franchise Fund, IT, etc.):

[X] IT Funds

3. Description of Supplies or Services.

[X] Software iMedRIS Software Maintenance Support Agreement Part Number: Software Rental and License-T4GCZAB55. iMedRIS is a brand-name software for Integrated Research Information System (iRIS). iMedRIS is a subsidiary of Cayuse Holdings LLC.

Part of or used with: iMedRIS is a focused suite of research compliance and administration software. This product is used in the study, design, development, enhancement, implementation, and support various aspects of research information and data. The solution includes an integrated software suite for Animal Management Solutions (e.g., IACUC & ARC), Human Subjects (e.g., IRB), Safety (e.g., SRSS, IBC), Research & Development Committee (SRB), Grants Administration (e.g., Pre/Post Award), Conflict of Interest, and other administrative solutions for the research community. The iMedRis sole product focus is on the development and maintenance of the iRIS product and its enhancement for research compliance and administration.

Quantity being procured: 1 Year Renewal & Maintenance, Base Year

Option quantity, if option will be included in solicitation: Four additional Option Years

Estimated unit cost:

Estimated total cost (including option quantity, if any):

4. Authority Cited.

iMedRIS/Integrated Research Information System (iRIS)Software/Maintenance

[X] FAR Overhaul 12.102(a)

For purchases not exceeding the simplified acquisition threshold. Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

[ ] Other FAR Authority _________________

5. Reason for Authority Cited.

The proposed source for this action is:

Cayuse Holdings, LLC (Cayuse) 1050 SW 6th Ave, Suite 1100 Portland, OR 97204

[ ] The supplies are urgently needed for the following reasons:

Non-availability of the item in a timely manner will have the following impact: N/A

[ ] Explain exclusive licensing agreements:

[X] Explain need for brand name:

iMedRIS is the only product in this market space. Based upon market research, as described in section 7 of this justification, it was determined that only the subject software has the capability to satisfy the department of Veterans Affairs San Diego Healthcare System requirement for the continuous use of single suite product to maintain research continuity. iMedRIS has been in place and significantly embedded in the required integration of services. Acquisition of new or different research data integration system or product would result in substantial duplication of costs exceeding $300,000 per year with additional investment in staff training and platform migration.

The compatibility and interoperability issues would prove insurmountable and impractical from a technical and operational standpoint, since it would require VA to purchase an entirely new infrastructure rather than expand on the existing infrastructure.

In addition, only Cayuse (iMedRIS) has access to the proprietary source code required for iMedRIS software maintenance support. Failure to acquire the renewal of iMedRIS software maintenance support would effectively bring the processing of research protocols to a halt. VA San Diego Healthcare System would not be able to process protocol submissions in a timely manner, which would significantly delay protocol approvals and funding applications. Further, VA San Diego Healthcare System would be unable to track animal use and costs, which would impact financial stability for the Veterinary Medical Unit, and unable to track animal use to protocol applications as required by federal regulations.

Efforts to Obtain Competition.

[X] There is only one responsible source for this item. Efforts made to locate additional sources are is no competition anticipated for this acquisition. Procurement data does not include any unnecessary requirements that may inhibit competition.

[ ] The sources proposed above are the only sources that can meet the urgent requirements for the reasons given above. Procurement data does not include any unnecessary requirements that may inhibit competition.

6. Actions to Increase Competition.

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be completed.

7. Market Research.

January 2026 through April 2026 by reviewing product websites of software similar to iRIS/iMedRIS to

. Other software platforms available such as IRBNet, Epic, and InfoEd Global were found to have similar offerings, however, it was determined that none of these products have access to the proprietary source code required to maintain the existing VA iMedRIS functional requirements and unable Only Cayuse owns the iRIS/iMedRIS software platform and all Proprietary Data necessary to support it. Based on the above market research, the other similar solutions are not able to provide access for VAs existing iMedRIS/iRIS data and attachments. Cayuse currently does not hold any Government Wide Acquisition Contract Vehicles.

8. Interested Sources.

None.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

10. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on FAR Overhaul 15.404-1 Price Analysis. Additionally, price discounts will be sought.

11. Contracting Officer Certification/Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.