JA_ MedidataRSR (FY24)__Redacted.pdf

Vendor: Medidata Solutions, Inc.

Period of Performance: 7/1/2022 � 6/30/2023 Award Amount: $1,676,828.77 Total Obligated: $1,209,880.72

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

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

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

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

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

Period of Performance: 3/24/2021 � 3/23/2022 Award Amount: $1,051,278.88 Total Obligated: $1,051,278.88

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

b. 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 are also options 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.

Requirement type.

Research & development (R&D) R & D support services

Support services (non-R&D)

Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): Renewal of services (Purchase Order 75N93023P00845)

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee):

Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________

Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. NOI-NIAID-24-2217784

c. Total estimated dollar value and performance/delivery period. Total estimated dollar value, inclusive of options, is Fiscal Year 2024 estimated funding to be obligated:$1,403,30 .90. Total period of performance is July 1, 2024 � June 30, 2025.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of FAR subpart 13.5 in accordance with 41 U.S.C. 1901.

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

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 three years. 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 labor costs in excess of $2.25 million would be required to replace Medidata exclusive of the cost of the new solution.

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 not reasonably available from other vendors without significant investment from NIAID:

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) General requirements the RSR System must meet include:

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 Provide training for key NIAID project team members and initial users in the capabilities and use of the System Prespecified workflow to support critical document management and source data review (SDR) activities tailored to NIAID�s monitoring approach

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 28, 2024 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 11, 2024 and no capabilities statements 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 Contracting Officer (CO) included reviewing NITAAC, GSA Advantage, and NASA SEWP market research tools for the company name �Medidata� and �Remote Source Review� which yielded no results for the required services. The CO conducted an SBA Dynamic Small Business Search (DSBS) that yielded no results for companies that could provide the required services. The search was conducted using 1) NAICS code �513210� and service �Remote Source Review�, 2) NAICS code �513210� and company name �Medidata�, 3) �Medidata�, and 4) �Remote Source Review�. The CO verified with Medidata that the required services are only available from them directly through the open market. Medidata confirmed they would be the sole provider of NIAID�s renewal and verified they do not offer the required SaaS and Professional Services through an existing government-wide contract such as NITAAC, GSA, or NASA SEWP. Additionally, NIAID did not receive any capabilities statements from 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 and support services.

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 submitted a capabilities statement in response 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 meet 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