JA redacted for SAM.pdf

Justification for Other than Full and Open Competition

�Source Selection Information � see FAR 2.101 and 3.104�

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. DHHS/National Institutes of Health [NIH]/National Institute of Allergy & Infectious Diseases [NIAID]/Acquisitions Management Operations Branch [AMOB]

b. Sponsoring organization. National Institute of Allergy and Infectious Diseases [NIAID], Office of the Director [OD], Office of Science Management and Operations [OSMO], Office of Cyber Infrastructure and Computational Biology [OCICB], Clinical Informatics Branch (CIB)

c. Project Officer information.

Project Officer name.

Mailing address.

E-mail address.

Telephone number.

Nature and/or description of the action being approved.

Acquisition purpose and objectives. The purpose of this acquisition is to renew Medidata Remote Source Review (RSR) module licenses to manage clinical site monitoring performed by the Division of AIDS (DAIDS) within the National Institute of Allergy and Infectious Diseases (NIAID) in a validated environment in accordance with federal and international regulations. NIAID requires the procurement of Medidata licenses to continue to provide RSR capabilities for a 12-month period, with the option to expand the number of licenses if required.

Project background. In support of the research mission, NIAID requires renewal of Medidata RSR to continue support for the urgent needs related to remote site monitoring of ongoing clinical trials within the DAIDS. Through this procurement, Medidata will continue to deliver the Medidata RSR application implementation and basic user training for the remote document capture needed to support remote site monitoring.

Services include configuration of the application to fit the requirements of DAIDS investigators. The RSR application will be implemented for 70 ongoing DAIDS protocols. This application is vital to ensure that clinical trials can continue operations and meet appropriate regulatory and human subjects research requirements while minimizing the COVID-19 risk for all investigators and site monitors.

Purchase Order: 75N93022P00793 Vendor: Medidata Solutions, Inc.

Period of Performance: 7/1/202 � 6/30/202 Total Obligated: $1,053,880.72

Purchase Order: 75N93022P00701 Vendor: Medidata Solutions, Inc.

Period of Performance: 5/24/2022 � 6/23/2022 Total Obligated: $91,820.01

Purchase Order: 75N93022P00501 Vendor: Medidata Solutions, Inc.

Period of Performance: 3/24/2022 � 5/23/2022 Amount: $183,150.00

Purchase Order: 75N93021P00398 Vendor: Medidata Solutions, Inc.

Period of Performance: 3/24/2021 � 3/23/2022 Amount: $876,778.88

The required Medidata SaaS licenses are proprietary to Medidata Solutions Incorporated and available only through Medidata.

3. Description of the supplies or services required to meet the agency�s needs (including the estimated value).

a. Project title. Medidata Remote Source Review Software-as-a-Service for Electronic Monitoring of Clinical Studies

Project description. This requirement provides commercial-off-the-shelf (COTS) Medidata RSR SaaS and supporting services. The Medidata licenses require annual renewal to continue use of this software and provide the highest level of customer support. There is no software or hardware to install or manage, and Medidata provides upgrades annually.

The COTS software includes subscription services for 70 studies and professional services for ongoing post Go-live support for those studies.

There are options for up to 15 additional subscription licenses and active study support. There is also an option for additional study builds of up to 30 studies during the performance period. Professional services are fixed services using Medidata�s structured delivery methodology for deployment to Client and management of project activities. Post-live support includes monthly project manager and implementation consultant hours to address concerns, technical issues, and questions. Professional services for new study builds includes implementation and basic user training for remote document capture using a standard RSR configuration with standard document quality control workflow and form that captures information about the document quality and existence and redaction of personal identifiable information and protected health information.

Services will also include the addition of a �Regulatory Folder� for all new RSR studies, up to 55 existing live RSR studies, and three template studies.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Medidata Solutions, Inc.

350 Hudson Street 9th Floor New York, New York 10014 USA 212-918-1800

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). The NIAID requires a continued unified experience for its RSR software users with the flexibility to support electronic RSR for multiple clinical sites around the world. As the incumbent, Medidata Solutions, Inc. is uniquely qualified to provide these services as they currently provide RSR to NIAID and has been doing so for over a year.

Awarding this acquisition to another vendor and implementing a different RSR system is not a reasonable solution as it would cause significant cost increases for NIAID, and its partners stemming from the need to migrate data and retrain staff. NIAID, in its role as Sponsor of Clinical Trials, has developed internal procedures based on the Medidata solution. These internal procedures would also need to be updated and changed if the Institute were to adopt another system, causing delays and a gap in the monitoring of clinical trials, and potentially risk falling out of regulatory compliance.

In addition, the Medidata RSR software is tightly integrated with the Medidata Electronic Data Capture (EDC) software which DAIDS depends on for the collection of clinical data. Another remote source review software would not have the same level of integration or any integration with the DAIDS EDC system. Connecting the EDC system to a third-party remote source review software would be time consuming and expensive.

NIAID performed a price analysis of the cost of continuing the use of Medidata SaaS versus replacing it with a compatible system, if available, that meets all the NIAID requirements. The analysis shows that the labor cost to replace Medidata with a comparable SaaS will cost NIAID over $2.25 million. Based on this information, the Government would take an unacceptable risk if award were made to a vendor other than Medidata.

Medidata is a recognized industry leader in providing clinical trials support software to customers around the world. Current DAIDS data management centers leverage RSR and other Medidata tools and have a full understanding of how to use these tools for DAIDS clinical trials.

Medidata provides rapid implementation of the RSR solution by establishing a standard out-of-the-box configuration with a standard document Quality Control workflow and form that captures information about the document quality and existence and redaction of personal identifiable information (PII) and protected health information (PHI). The standard folders are used to capture documents for each trial focused on patient safety (adverse and serious adverse events, medications, drug dosing logs, etc.). Additional folders that may be needed will be configured to capture documents around key primary endpoints as specified by NIAID.

The following additional RSR System capabilities are required by NIAID and are currently being fulfilled by the incumbent, Medidata:

Support electronic signatures that meet the necessary regulatory requirements, in particular, 21 CFR Part 11 for electronic records, for all document approvals and procedural affirmations

Delivered with a Computer Systems Validation (CSV) package that provides documented evidence of compliance with regulatory requirements including 21 CFR 11, ICH E6 (R2), and GAMP 5 (or similar risk-based framework)

Enterprise solution capable of supporting all NIAID divisions within the Institute as well as external NIAID partners

General requirements the RSR System must meet include:

Security features to restrict and report unauthorized access attempts Support configurable metadata and naming conventions on a per Division basis Section 508 compliant in a way that is efficient to develop, implement, test, and use by all members of the NIAID user community

Offered as SaaS and/or managed cloud solutions FISMA Moderate compliant Fully functional lower environments that are configured identically to the production environment for testing and training

Support inspections conducted by internal and external regulatory agencies, government entities, and organizations engaged or authorized by NIAID

Provide structured submission process to minimize errors with a prespecified workflow to support critical document management and Source Data Review activities including mobile device upload options

Offer intelligent task management and document routing with conditional logic to ensure all tasks are in the right place for the right site

Provide standard reports for task management and status updates so monitors know the status of the visit

Software must have or be capable of search and find feature for automatic redaction; tracking of tasks with completed forms; 21 CFR Part 11 � compliant system; audit ready, including resolution of audit findings; and process for systematic permanent document removal

Provide seamless access to third parties and can access third parties

Qualified personnel to configure and implement the System and provide activities needed to support a fully operational System

Provide training for key NIAID project team members and initial users in the capabilities and use of the System

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. As required by FAR Subpart 5.2, a Presolicitation Notice of Intent (NOI) to award a sole source purchase order was publicized on May 31, 2023 on SAM.gov for 15 days announcing the Government�s intent to renew NIAID�s Medidata RSR SaaS. The announcement indicated the reasoning for awarding a purchase order without competition. The notice closed on June 14, 2023 and no responses to the Presolicitation NOI were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at a fair and reasonable price.

NIAID will consider comparison with the independent government estimate, and proposed prices found reasonable on previous orders as a determining factor for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The Program Office conducted the initial market research by reviewing NIAID�s existing clinical trials support software and scanning the market for technology that could satisfy the Government�s requirement for remote site monitoring. Their research concluded that Medidata Solutions, Inc. is the only source of technology that can meet NIAID�s needs. RSR is a proprietary product of Medidata. All product source code, database structures, technical documentation, installation instructions, sub-components, requirements specifications, design artifacts, user manuals, etc. are the intellectual property of Medidata which reserves all rights.

Market research conducted by the Contract Specialist (CS) included reviewing previous purchases of similar acquisitions; contacting knowledgeable individuals in government and industry regarding market capabilities to meet requirements;

NITAAC and GSA Advantage market research tools; and online research. The CS verified with Medidata that the required products/services are only available from them directly through the open market. Medidata products/services are not available through existing government-wide contract vehicles such as GSA Federal Supply Schedules. Medidata confirmed they would be the sole provider of NIAID�s renewal and verified they do not offer the SaaS through an existing government-wide contract such as NITAAC, GSA, or NASA SEWP. Additionally, NIAID did not receive any inquiries to the Notice of Intent to Sole Source that was posted on SAM.gov for this requirement. In conclusion, the market research supports a sole source award to Medidata Solutions, Inc. as the only source available to the Government for the renewal of these SaaS licenses.

9. Any other facts supporting the use of other than full and open competition.

Not applicable.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No sources expressed an interest, in writing, to the Presolicitation Notice that was published on SAM.gov indicating intent to issue a sole source award to Medidata Solutions, Inc.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. To remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government�s requirement. The NIAID IT staff meets regularly with manufacturers and vendors and attends manufacturer and industry training to keep current on technology.

Vendor and trade magazines are scanned for new, open technologies that can satisfy future regulatory support requirements. The agency will continually re-evaluate the software currently being used and will research manufacturers and products that will be in the Government�s best interest as best value for future replacement software at the agency�s site and at sites the agency supports. The current situation requires a validated commercial off-the-shelf tool and services to satisfy agency requirements. Since NIAID�s current RSR solution is comprised of Medidata SaaS, no further actions are planned to overcome this barrier.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government�s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

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