Limited Source Justification ClinicalTrials.gov-Signed.pdf

Limited Source Justification

“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.

Department of Health and Human Services (HHS) National Institutes of Health (NIH)

b. Sponsoring organization.

National Institutes of Health (NIH) National Library of Medicine (NLM) National Center for Biotechnology Information (NCBI)

c. Project Officer information.

Project Officer Name: Anna Fine

Mailing Address:

National Center for Biotechnology Information National Library of Medicine 8600 Rockville Pike, Bldg., 38A, B1 Rm. B1N30F Bethesda, MD 20894

E-mail Address: anna.fine@nih.gov

Telephone Number: 301-443-5063

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this requirement is to acquire professional support for the provision of biomedical and clinical information services to the public. NLM is responsible for the legislatively mandated ClinicalTrials.gov information resource which, in part, is supported by this contract.

The objective is to issue a sole-source award to ICF Incorporated LLC under Task Order GS00F010CA-75N97023F00106 by exercising Option to Extend Services per FAR 52.217-8. At the time of this Task Order award, the Government incorporated FAR 52.217-8 into the Task Order; however, the cost associated with exercising this option was not evaluated or negotiated. As a result, the Government must now enter into a new procurement action to extend services under this clause. This option will allow for the continuity of services for six (6) months from March 27, 2025, to September 26, 2025, until a new contract is put in place.

b. Project background This acquisition was initially established to support the ClinicalTrials.gov at the National Library of Medicine (NLM). ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). It was created to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications. The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database.

NLM aims to promote and stimulate the advancement of data science and open science throughout biomedical research and application and leads efforts to support and catalyze open science, data sharing, and research reproducibility, striving to promote the concept that biomedical information and its transparent analysis are public goods.

This contract supports various tasks aligned with new and expanding Congressional mandates, changing policies and information technologies, NIH research programs, and NLM's role in the NIH community.

This project started with Task Order 75N97020A00019/75N97020F00002, awarded to ICF Incorporated. This Task Order was procured using competitive procedures under GSA FSS for a period of performance of 09-29-2020 through 09-28-2023. Current Task Order, GS00F010CA/75N97023F00106, included a 12-month base period plus 6-month option per FAR 52.217-9 Option to Extend the Term of the Contract and Option to Extend Services, not to exceed 6 months, per FAR 52.217-8. Through this effort, NIH has made major investment in the ClinicalTrials.gov modernization effort enhancing the system’s information infrastructure. The work recently deployed includes an upgraded user-focused design and modularized submission system with optimized workflow management. Key users expect modifications to be resolved by the end of this fiscal year;

therefore, critical user feedback needs to be addressed to minimize discrepancies and to ensure a smooth transition to the new modernized Protocol Registration and Results System (PRS) as we complete this multi-year effort. Additionally, the remaining usability testing performed by the contract still needs to be validated, which is essential to the newly launched submission process.

Strategic decisions are pending regarding the integration, continuation and closure of NLM programs and the transition of some services from one program area or other NIH IC or HHS department to another. Amidst the transition, there is a need to continue services for mission critical tasks, such as ClinicalTrials.gov, since it is required by Federal law (42 USC 282(j)) that the NIH collect registration and results information for all clinical trials regulated by the FDA.

Although significant progress has been made pertaining to the modernization of ClinicalTrials.gov, exercising the Option to Extend Services per FAR 52.217-8 from March 27, 2025, to September 26, 2025, will provide NLM the necessary time to complete the modernization phase and NLM cannot risk interruption of clinical trial registration and results reporting as mandated by Congress.

Since the modernization is now nearing completion, the Program Office anticipates pursuing a new post-modernization procurement to support the long-term maintenance and evolution of ClinicalTrials.gov after September 2025. This 6-month extension allows for continuity of operations until the modernization is complete and a follow-on procurement strategy for post-modernization is finalized and implemented.

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

a. Project title: Operations, Maintenance, and Modernization Support for

ClinicalTrials.gov

b. Project description.

The scope of this requirement is to acquire complex professional specialized expertise to support the operations, maintenance, and modernization of ClinicalTrials.gov.

Requirement type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify):

Type of action.

New requirement Follow-on: 52.217-8 Option to Extend Services under Task Order

GS00F010CA-75N97023F00106

Other (specify):

Proposed contract/order type.

Firm-Fixed-Price Time and Materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

Other (specify): Hybrid (FFP & T&M)

Acquisition identification number: N/A

c. Total estimated dollar value and performance/delivery period.

Period of Performance Cost

Base Period 09/27/2023 – 09/26/2024 $17,472,346.00

Option Period One 09/27/2024 – 03/26/2025 $8,184,682.00

Optional Quantity 03/01/2025 – 03/26/2025 $400,000.00

Option to Extend Service 03/27/2025 – 09/26/2025 Estimated at $8,132,837.00

4. Identification of the justification rationale [see 8.405-6(a) and (b)] and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

This acquisition is conducted under the authority of the Multiple Award Schedule

Program. Consideration of schedule contractors will be restricted to fewer than the number required by Federal Acquisition Regulation (FAR) 8.405-6(a)(1)(C) - In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. Consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer as provided in FAR 8.405-6(a)(2).

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

Name and address of the proposed contractor(s).

ICF Incorporated (ICF) 9300 Lee Highway, Room 876 Fairfax, VA 22031

Nature of the acquisition and proposed contractor(s) unique qualifications.

As previously mentioned, ICF Incorporated began supporting Operations & Maintenance and Modernization in 2020 and is currently working on upgrading user-focused designs and deploying a modularized submission system with optimized workflow management. Ongoing pilots and usability testing performed by the contractor still need to be implemented.

The ClinicalTrials.gov program is at a critical juncture in its modernization effort, with major deliverables scheduled over the next six months. These include the completion of the clinical trials results module and the transition of 50% of users to the modern system. ICF Incorporated contractor is fully engaged in these efforts and possesses the necessary expertise to ensure their timely completion. Bringing in a new contractor at this stage would introduce substantial delays, as they would need to acquire a deep understanding of the system’s unique validation rules, regulatory requirements, and technical infrastructure. End users currently rely on two separate systems to complete their clinical trial results submissions. Adding a transition period with a new vendor would force them to operate under even greater inefficiencies, requiring both the incumbent and the new contractor to work in parallel while knowledge transfer takes place. This approach would slow down production and compromise operational efficiency, resulting in a poor return on investment for the U.S. Government.

Complicating the transition further, there is limited system documentation for ClinicalTrials.gov’s validations and technical architecture. Much of the system has been developed over decades, meaning that many business rules and regulatory requirements have been reverse-engineered by ICF Incorporated to accommodate legacy data and new data structures. For example, the system must account for policy nuances such as whether a clinical study is NIH-funded, classified as an Applicable Clinical Trial (ACT), or falls under the final rule enacted on January 18, 2017. These distinctions impact data validation and regulatory compliance and must be properly understood to ensure backward compatibility with legacy records. A new contractor would have to learn these complex interdependencies from scratch, introducing significant risks to the project timeline.

The ClinicalTrials.gov system has evolved over 25 years, accommodating complex legal and regulatory mandates. During this time, the program and technical staff have developed substantial institutional knowledge and practical experience in the clinical research transparency domain. ICF Incorporated contractor had to navigate a steep learning curve when they first took over modernization efforts in 2021, particularly after the unexpected departure of key NIH staff in Year 2, which resulted in the loss of deep institutional and technical knowledge. Despite these early setbacks, ICF Incorporated successfully launched the standalone modernized ClinicalTrials.gov in mid-2024 (Year 5) as planned.

However, critical work remains. ICF Incorporated is still actively refining the modernized Protocol Registration System (PRS), particularly in the area of identifying and replicating validation rules to ensure backward compatibility for older studies. This work requires an in-depth understanding of both the legacy and modernized PRS systems, research program needs, and compliance with clinical trial regulations. Bringing in a new contractor at this stage would delay the completion of the PRS modernization and extend the need to support the outdated classic PRS indefinitely until the new system is fully operational.

A six-month transition period would be insufficient for a new contractor to achieve the incumbent’s level of expertise. The extension period authorized by the Government includes specific, time-sensitive deliverables, including the completion of results submissions, adverse event tracking, and in-line module commenting features. ICF Incorporated developed the commenting functionality for clinical trial results records and is currently refining the context-specific implementation within the PRS modules. The existing roadmap requires this functionality to be in production by Summer 2025. A new contractor would need months to learn the requirements, validation rules, and existing comments, followed by additional time to complete development and testing. Instead of spending six months onboarding a new team, NLM is prioritizing the completion of results modules, ensuring that users can fully transition to the modern system for trial submissions within the extension period. Any delay in this transition would burden users by forcing them to continue navigating both the modern and classic systems unnecessarily.

ICF Incorporated has specialized expertise in ClinicalTrials.gov modernization, particularly PRS modernization, which they have been leading since Fall 2021. Their contributions include:

Discovery and documentation of PRS business rules Reverse-engineering and analysis of the classic PRS infrastructure and codebase Documenting highly complex data validation rules

ICF Incorporated’s direct contributions include in-depth analysis of the database schema, system infrastructure, and legacy business logic. Their expertise in reverse-engineering undocumented validation rules has been instrumental in ensuring that data integrity is maintained across legacy and modernized systems. The technical challenges of this modernization effort extend beyond general IT capabilities, requiring extensive knowledge of ClinicalTrials.gov’s regulatory and scientific frameworks.

A new contractor would require 6 to 8 months to ramp up, even with prior experience in legacy system replacement. The classic PRS system relies on proprietary, sparsely documented tools, such as:

BSE (a custom-built tool developed in-house) – The original developer of this tool has since retired, leaving limited institutional knowledge available.

POLKA (a legacy operations/monitoring tool) – Known for being unreliable and requiring manual workarounds.

ICF Incorporated has gained deep expertise in navigating and troubleshooting these tools, making them uniquely qualified to complete modernization efforts without compromising project timelines.

The risks of transitioning to a new vendor at this stage are substantial. ICF Incorporated is the only vendor capable of mitigating risks related to schedule slippage, duplication of effort, and loss of institutional knowledge. Each scheduled release introduces new validation challenges, which the ICF Incorporated is already equipped to address. A new vendor would lack this historical knowledge, significantly delaying the completion of modernization milestones. The departure of prior institutional knowledge from NLM in 2021 underscores the importance of continuity with ICF Incorporated, as they have spent years acquiring and refining their understanding of the system. Attempting to transfer this knowledge within a short transition period would disrupt momentum and jeopardize the final deliverables.

From a cost perspective, continuing with the incumbent outweighs any potential savings associated with transitioning to a new contractor. Training and onboarding a new team would increase the period of performance for key deliverables, potentially leading to an extended contract timeline. If a new vendor fails to meet expectations, the Government could face a loss of investment and additional costs to correct deficiencies. Given the complexity of this project and the risks associated with changing vendors, retaining ICF Incorporated for the six-month extension is the best value for the Government.

ICF Incorporated possesses the highly specialized experience and technical expertise necessary to meet the Government’s needs for this complex and evolving requirement. Several critical services are in the final stages of evaluation and modernization, and transitioning to a new vendor at this point would result in excessive delays, significant costs, loss of institutional knowledge, and unacceptable risks to mission continuity. The knowledge and skills required to perform this work are not readily available in the open market and cannot be rapidly acquired by another vendor without severe operational and compliance consequences.

The contractor is the only known source capable of meeting NLM’s short-term requirement without disruption while the recompete effort is conducted. Their key personnel are indispensable to the Congressionally mandated work of ClinicalTrials.gov, ensuring uninterrupted access to clinical trial registration and results data essential to the FDA, NIH, medical community, and the public. A lapse in service would compromise compliance with federal mandates and hinder NLM’s ability to fulfill its core mission.

The proposed six-month extension is critical to completing the final phase of the Protocol Registration System modernization and ensuring a structured ramp-down of services. ClinicalTrials.gov has reached the culmination of a high-profile five-year modernization effort, and the contractor’s continued support is essential for troubleshooting, final feature implementation, and managing the influx of weekly records. The incumbent's deep institutional knowledge and seamless integration with ongoing efforts make them the only responsible source capable of completing this work without unacceptable delays or additional costs.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

Pursuant to FAR 8.404(d), the Government has determined that this extension represents the best value based on pricing reasonableness, avoidance of unnecessary transition costs, and continuity of mission-critical services. The contractor's pricing is based on GSA Federal Supply Schedule (FSS) rates, which have already been determined fair and reasonable by GSA, ensuring competitive pricing in the market.

The cost for this extension will be consistent with the current period of performance rates and may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor, thereby maintaining cost predictability. Awarding this extension avoids the significant costs and delays associated with transitioning to a new vendor, which would require additional time for knowledge transfer, onboarding, and process integration, resulting in potential operational inefficiencies.

Additionally, the incumbent’s personnel possess the unique expertise and historical knowledge essential to the successful completion of the final phase of the Protocol

Registration System modernization. Given the critical nature of this requirement and the need to maintain compliance with Congressional mandates, extending the current contract for six months ensures continuity of operations without disruption while providing the Government with the best value solution

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

Market research was conducted in both the open market and GSA Federal Supply Schedule from August 27, 2024, through September 5, 2024, prior to exercising Option Period One (1). As part of this effort, two Sources Sought Notices were issued (75N97024Q00085 & RFQ1722389), one on SAM.gov and another on GSA eBuy, resulting in the receipt of 49 capability statements from both large and small businesses, including vendors from various socio-economic categories.

A review of the capability statements determined that none of the responding vendors, except for the incumbent contractor (ICF Incorporated), demonstrated the ability to perform the full scope of work for Operations, Maintenance, and Modernization Support and post-modernization efforts.

The review revealed that none of the responding vendors demonstrated the full range of expertise required to successfully perform the contract requirements. Specifically, most vendors lacked experience with the technology stack outlined in the Statement of Work (SOW) (Tasks 3-5), including Java, Kotlin, Python, and other frameworks essential for the modernization effort. While some vendors had IT modernization experience, their capabilities were often limited to different platforms, such as .NET, SharePoint, or Salesforce, which do not align with NIH’s system architecture. Additionally, several vendors specialized in data processing but lacked experience developing complex user interfaces, a critical requirement of the modernization effort.

Beyond technical expertise, the majority of vendors also lacked scientific and clinical trials experience (Task 2). Many had no demonstrated capability in reviewing clinical trial data for scientific accuracy, regulatory compliance, or protocol validation, all of which are essential for maintaining ClinicalTrials.gov. Some vendors cited experience with medical data processing but did not show familiarity with clinical trial operations, NIH’s regulatory environment, or quality assurance of trial submissions. A few vendors had some exposure to clinical trials but did not provide sufficient evidence of their ability to manage the full scope and complexity of the project.

Additionally, several vendors failed to demonstrate experience handling projects of this size and complexity within the biomedical and clinical research domain. Some vendors noted general federal IT experience but had backgrounds in call center operations, commercial health applications, or unrelated public health initiatives, which do not translate to the specific needs of ClinicalTrials.gov. Others indicated that they would require a teaming arrangement or subcontractors to meet the contract’s full scope, introducing potential risks to performance, cost, and schedule. Notably, some vendors provided capability statements that did not address the SOW tasks at all, further confirming their lack of relevant expertise.

Overall, the market research findings indicate that no alternative vendors demonstrated full capability in both IT modernization and clinical trial operations. The technical, regulatory, and operational complexities of ClinicalTrials.gov require a contractor with deep institutional knowledge and expertise across all required domains.

The primary barrier to competition appeared to be the ongoing modernization phase of the system, which requires specialized expertise and in-depth institutional knowledge. At the time the sources sought was issued and capability statements reviewed, it was determined around December 2024 that an additional nine (9) months would be needed to complete the modernization effort and create an open competition for the future version of ClinicalTrials.gov. The end date at this time is March 27, 2025; therefore, an additional 6 months is needed from March 2025 through September 2025.

7. Any other facts supporting the justification.

ClinicalTrials.gov is the world’s largest clinical trial registry and results database, supporting global research transparency and public health. As of February 2025, it contains over 525,000 registered clinical studies, with 850–1,200 new studies added weekly across all 50 states and more than 220 countries. The results database includes over 65,000 studies, with 350–450 new results submissions each week, and the platform hosts approximately 100,000 visitors daily. Given that NIH is the largest U.S. federal funder of clinical trials, ensuring the seamless operation of ClinicalTrials.gov is critical to maintaining the integrity of publicly accessible clinical research data.

The modernization of ClinicalTrials.gov is essential to NIH’s ability to make informed funding decisions, prevent unnecessary duplication of trials, and ensure the responsible dissemination of clinical research. High-profile stakeholder engagement efforts, including public meetings in April 2020 and April 2023, have created strong expectations for a smooth transition to the modern system. Stakeholders are currently in the process of migrating from the classic system to the modern Protocol Registration and Results System (PRS), and this additional six-month period is necessary to ensure proper user adoption. Without sufficient transition support, many stakeholders may resist the change, making it more difficult to retire the classic PRS and shift entirely to the modern system.

This extension is also vital to finalizing critical infrastructure upgrades, including transitioning to a new cloud platform and deploying the remaining system features. The incumbent contractor has been integral to these efforts, leveraging its deep institutional knowledge to troubleshoot, refine, and implement key enhancements informed by stakeholder feedback. A lapse in service at this critical juncture could lead to delays, operational inefficiencies, and diminished confidence in the modernization effort. Moreover, stakeholders have high expectations for the modernization to continue progressing at a steady pace, and any disruption could lead to frustration and decreased adoption of the modern PRS.

Now that the modernization project is nearing completion, replacing the incumbent contractor would create significant risks, including loss of critical expertise, delays in deployment, and an inefficient transition to the next awardee. The knowledge required to complete this initiative is highly specialized, and introducing a new contractor at this stage would result in additional ramp-up time, higher costs, and a potential loss of momentum in this high-profile project.

As the modernization effort is now in its final phase and is anticipated to be completed on or before September 2025, this six-month extension under FAR 52.217-8 is necessary to ensure continuity of operations until modernization is finalized.

Given the contractor’s unique qualifications and the unacceptable impact of service disruption, awarding this 6-month extension under FAR 8.405-6(a)(1)(C) is necessary to ensure the Government maximizes its investment in modernization, minimizes risk, and maintains compliance with NIH’s Congressionally mandated responsibilities, making it the only responsible course of action.

Additionally, this extension will also allow time for the Government to complete its follow-on procurement strategy for post-modernization requirements and implement a competitive acquisition approach that fosters greater participation from qualified vendors.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a. Removal of barriers to competition.

The primary barrier to competition has been the ongoing modernization phase, which required specialized expertise, proprietary knowledge, and institutional knowledge with the system's evolving technical framework. However, when the modernization portion of the work is excluded, market research shows at least two small businesses in GSA are capable of supporting the long-term, post-modernization requirements. As a result, market research indicates that only the incumbent contractor possessed the necessary qualifications to perform the full scope of work. However, with the modernization effort nearing completion and anticipated to conclude on or before September 2025, the Government is actively taking steps to broaden competition for future procurements.

Recent market research has identified multiple vendors, including at least two women-owned small businesses, that are capable of supporting the post-modernization requirements. To facilitate a more competitive environment for the follow-on procurement, the agency is:

Defining the future scope of work to exclude modernization-specific activities, ensuring that more vendors, including small businesses, have the opportunity to compete.

Engaging with industry through Requests for Information (RFIs), industry days, and direct outreach to further assess vendor capabilities and inform acquisition planning.

Developing a procurement strategy that encourages competition, including consideration of small business set-asides where feasible.

Ensuring knowledge transfer and documentation during the transition period to reduce dependency on any single vendor and facilitate broader participation in future procurements.

To support this effort, the six-month extension will include a structured transition plan to maintain the quality and integrity of ongoing work while ensuring a smooth handoff to future contractors. This transition period will allow for knowledge transfer, process documentation, and system stabilization, mitigating the risks associated with vendor turnover and ensuring the continuity of mission-critical services.

By implementing these measures, the Government is actively working to remove barriers to competition and ensure a more competitive acquisition environment for the post-modernization phase, allowing for increased vendor participation while maintaining the integrity and continuity of critical services.

b. Listing of sources, if any, that expressed an interest, in writing, in the acquisition.

As previously indicated, it was the Government’s intention to exercise the Option to Extend Services of Task Order GS00F010CA-75N97023F00106 per FAR 52.217-8 given the unpredictable timing of the modernization completion, but the costs weren’t evaluated at award. As a result, the Government must now enter into a new procurement action to extend services under this clause.

As noted in the market research, 49 contractors responded to the Sources Sought Notices issued via SAM.gov and GSA eBuy for the upcoming recompete. Upon completion of the modernization phase, it is expected that some of these contractors will compete for the forthcoming requirement.

A Notice of Intent 75N97025Q00028 was issued via Sam.gov on 02/28/2025 with closing date of 03/07/2025; no responses were received.

9. 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 or requirements, or other rationale for limited sources, are accurate and complete.

Official Name & Title Signature Date

Project Officer Anna M. Fine, PharmD, MS, Acting Program Head, ClinicalTrials.gov

Project Officer’s Immediate Supervisor

Valerie Schneider, Acting Branch Chief, IEB, NCBI

Head of the Sponsoring Program Office

Kim Pruitt, Acting Director, NCBI

10. Contracting Officer certification.

Anna M. Fine -S Digitally signed by Anna M. Fine -S Date: 2025.03.23 19:05:55 -04'00'

VALERIE A.

SCHNEIDER -S

Digitally signed by

VALERIE A. SCHNEIDER

-S Date: 2025.03.21 15:56:31 -04'00'

Kim D.

Pruitt -S

Digitally signed by Kim D. Pruitt -S Date: 2025.03.21 15:59:02 -04'00'

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer Delfo Sacomizhquiri, Contracting Officer, Office of Acquisitions, NLM

11. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting Office

Daniel J. Hartinger Director, Office of Acquisitions, NLM

Head of the Contracting Activity for Olga M. Acosta Director, OALM, OD, NIH Head of the Contracting Activity, NIH

12. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

Dr. Kathryn Partin, Ph.D., Director of Research Integrity, OIR, OD, NIH

Delfo Saco Mizhquiri -S

Digitally signed by Delfo Saco Mizhquiri -S Date: 2025.03.24 08:03:32 -04'00'

Digitally signed by Daniel J. Hartinger -S Date: 2025.03.24 14:31:06 -04'00'

TIFFANY D.

CHADWICK

-S

Digitally signed by TIFFANY D.

CHADWICK -S

Date: 2025.03.26 10:03:43 -04'00'

Kathryn M.

Partin -S

Digitally signed by Kathryn M. Partin -S Date: 2025.03.26 11:27:01 -04'00'