JA_eTMF_Trial_Interactive_FY24_Redacted.pdf

“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. National Institutes of Health (NIH), National Institute of Allergy & Infectious Diseases (NIAID), Division of Extramural Activities (DEA), Office of Acquisitions (OA)

b. Sponsoring organization. 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.

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

a. Acquisition purpose and objectives.

The purpose of this acquisition is to renew TransPerfect’s Software-as-a- Service (SaaS) electronic Trial Master Files (eTMF) licenses, enabling the management of Trial Master Files across multiple Divisions within NIAID in a validated environment that complies with federal and international regulations.

Through this procurement, TransPerfect will continue to deliver support for the Trial Interactive software, including implementation and end-user training for NIAID staff to manage their Trial Master Files electronically. Services will also include configuration of the application to fit the requirements of the Divisions’ staff supporting clinical trials.

The Trial Interactive application will be implemented for at least four ongoing research protocols. This application is essential for ensuring that critical documents from clinical trials are captured in an inspection-ready system, thereby supporting NIAID’s responsibilities as a sponsor of clinical research.

NIAID requires the procurement of TransPerfect licenses and support services to maintain eTMF capabilities for a 12-month period, with options to expand the number of licenses and services for additional studies if needed. This requirement is for a sole-source acquisition of commercial services and will be

Justification and Approval for Other than Full and Open Competition

Sole-Source conducted pursuant to FAR Subpart 13.5.

b. Project background.

In 2022, NIAID made a strategic decision to address electronic Trial Master Files (eTMF) at an Enterprise (Institute-wide) level. After conducting comprehensive market research, NIAID acquired TransPerfect’s software through contract Other Direct Costs (ODCs). TransPerfect constructed and deployed NIAID’s dedicated instance of Trial Interactive in mid-2023 and continues to provide support for the Trial Interactive eTMF software and IT infrastructure resources for NIAID. Currently, three NIAID Divisions are in various stages of onboarding their eTMF study rooms to the Trial Interactive system, with additional division expected to add more TMFs to the system.

Annual licensing is essential to continue using the software and to ensure ongoing support and upgrades from TransPerfect. This renewal of the software subscription will provide the necessary licensing, maintenance, and support required to successfully execute this initiative.

This firm-fixed price requirement pertains to the renewal of the existing TransPerfect Trial Interactive eTMF software subscription. This software supports the Trial Master Files for the Division of AIDS (DAIDS), Division of Microbiology and Infectious Diseases (DMID), Vaccine Research Center (VRC), and potentially other NIAID Divisions. TransPerfect’s software is crucial for managing essential documents related to NIAID’s role as a sponsor of clinical trials. The continuity of service provided by this acquisition is vital for maintaining regulatory compliance of multiple groups within NIAID and for supporting users at NIAID facilities.

Initially, the Institute acquired the TransPerfect software through ODCs on Booz Allen Hamilton’s contract. Booz Allen Hamilton assisted with the initial configuration of the software.

Contract/Order ID: HHSN316201200008W/14D0419F0318

Contractor: Booz Allen Hamilton Inc.

Period of Performance: 9/4/2019 – 9/3/2024 Award Amount: $147,482,282.56 Total Obligated: $116,490,020.21

The required TransPerfect Trial Interactive eTMF SaaS licenses are proprietary to TransPerfect Incorporated and can only be obtained directly from TransPerfect.

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

a. Project title.

Electronic Trial Master File (eTMF) Trial Interactive Software-as-a-Service for Clinical Studies

b. Project description.

This requirement involves the provision of commercially available TransPerfect Trial Interactive eTMF SaaS and supporting services. The TransPerfect Trial Interactive licenses, which include both full and view-only options, require annual renewal to ensure continued use and access to the highest level of customer support. As a cloud-based solution, there is no software or hardware to install or manage, and TransPerfect provides annual upgrades.

The proposed acquisition will include quantity options for additional full and view-only licenses, as well as support services for implementation and training.

For the support services component, the contractor will supply qualified personnel to configure and implement the System, ensuring it is fully operational. Initial tasks will include training key NIAID project team members and initial users on the System’s capabilities and usage, determining and documenting NIAID requirements, configuring, evaluating, and revising master templates and study rooms configuration, and finalizing and deploying to production.

Ongoing tasks will focus on the operation and support of the production System throughout the performance period. Options are included to provide three divisions with customized training, configure new Master Templates, build up to eight additional study rooms, and offer consulting and TMF study owner support services. Additional options include building up to three more rooms for Master Templates, maintaining up to two User Acceptance Testing (UAT) rooms, supporting up to 12 small study sites, supporting up to 12 medium study sites, and providing up to 50 additional hours for project management, implementation and technical services. Onsite training from TransPerfect is also included.

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 (Contract/Order

HHSN316201200008W 14D0419F0318)

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-24-2227411

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 is Total period of performance is September 4, 2024 – September 3, 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 United States Code (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).

TransPerfect Translations International Inc.

1250 Broadway, FL 7 New York, NY 10001-3749

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

The NIAID requires a flexible solution to support the eTMF of multiple Divisions.

NIAID has been utilizing TransPerfect’s Trial Interactive eTMF system, which allows researchers to manage their documents in an inspection-ready repository that complies with clinical regulatory requirements. Currently, multiple Divisions within NIAID are represented among the system’s users. As the incumbent provider, TransPerfect is uniquely qualified to continue offering these services, having successfully supported NIAID for over two years. The TransPerfect SaaS has been specifically configured for these groups, ensuring consistent operations within the existing NIAID environment.

Switching to another vendor and implementing a different eTMF system is not a viable solution, as it would result in significant cost increases for NIAID due to the need for reconfiguration and staff retraining. Additionally, NIAID has developed internal procedures based on the TransPerfect solution. Adopting a new system would necessitate updating and changing these procedures, causing delays, gaps in trial documentation management, and potentially risking regulatory compliance.

NIAID conducted a price analysis comparing the cost of continuing with the Trial Interactive eTMF SaaS versus replacing it with a compatible system that meets all NIAID requirements. The analysis revealed that labor costs alone would exceed $1 million to replace TransPerfect, excluding the cost of the new solution. Based on this information, awarding the contract to a vendor other than TransPerfect would pose an unacceptable risk to the Government.

TransPerfect is the only known source capable of fulfilling all NIAID requirements, which includes:

A mature SaaS solution enabling users to maintain controlled documents in a validated environment in compliance with regulatory requirements.

Strict adherence to the CDISC eTMF reference model while allowing custom metadata and configurable access control.

Support for Computer Systems Validation and 21 CFR Part 11 compliance.

The ability for authorized users and NIAID leadership to view, in detail and at a high level, the health and completeness of Trial Master Files.

Configuration flexibility for multiple groups, accommodating differences in how essential documents are captured.

Providing the same TransPerfect solution across multiple Divisions within NIAID offers numerous opportunities for process integration, collaboration, and labor cost savings. Due to the proprietary nature and protection of the software source code, product-specific software and technical support are only available through TransPerfect. TransPerfect Trial Interactive SaaS remains the only viable option.

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 August 15, 2024, on SAM.gov for 15 days, announcing the Government’s intent to renew NIAID’s TransPerfect SaaS. The announcement indicated the reasoning for awarding a purchase order without competition. The notice closed on August 30, 2024, and two responses were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The techniques outlined at FAR 13.106-3(a)(2) will be employed to ensure that the award is made at a fair and reasonable price. NIAID will consider factors such as the independent government estimate, and proposed prices deemed reasonable on previous contracts to determine price reasonableness. A final determination by the Contracting Officer will be conducted prior to awarding 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 initial market research by reviewing NIAID’s existing eTMF system and scanning the market for technology capable of meeting the Government’s requirements for managing clinical trial documentation. Their research concluded that TransPerfect SaaS is the only technology that can meet NIAID’s eTMF system requirements. Trial Interactive is a proprietary product of TransPerfect, and all associated product source code, database structures, technical documentation, installation instructions, sub-components, requirements specifications, design artifacts, user manuals, etc., are the intellectual property of TransPerfect, which reserves all rights.

Additional market research included a review of mandatory priorities in accordance with FAR Subpart 8.002(a)(1) Priorities for Use of Government Supply Sources. The Contracting Officer (CO) determined that none of the mandatory Government sources could satisfy this requirement. Other market research efforts included reviewing previous eTMF purchases and utilizing market research tools from NITAAC, NASA SEWP, and GSA Advantage to search for the company name “TransPerfect,” “Trial Interactive,” and “eTMF.” These searches yielded no results for the required services.

The CO also conducted an SBA Dynamic Small Business Search (DSBS) using keywords such as “TransPerfect,” “Trial Interactive,” “Trial Master File,” and “eTMF,” which yielded no viable results for small businesses capable of providing the required services. The CO contacted TransPerfect to inquire about possible authorized resellers for NIAID’s SaaS renewal. TransPerfect confirmed that they are the sole provider of NIAID’s renewal and verified that they do not offer the SaaS through existing government-wide contracts such as NITAAC, GSA, or NASA SEWP.

In conclusion, the market research supports a sole source award to TransPerfect, 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.

In response to the NOI posting, NIAID received inquiries from

After reviewing the information provided by both companies, NIAID determined that they offer alternate eTMF solutions to TransPerfect. However, transitioning to a new system would be cost prohibitive for the Institute due to the expenses associated with implementing, validating, and training all Division staff on the new software. Adopting a new system would also require updating and changing internal procedures, leading to delays, gaps in trial