Annual License for Trialtrove (Clinical Trial Data Intelligence Platform)

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with Cox Subscriptions, Inc. for Trialtrove.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS
The intended procurement is classified under NAICS code 513210 - Software Publishers with a Size Standard of $47.0 million.

REGULATORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures. Contracts awarded using FAR Part 13 Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6 Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: 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 (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04 dated June 2, 2023.

DESCRIPTION OF REQUIREMENT
PURPOSE AND OBJECTIVES:
The National Center for Advancing Translational Sciences (NCATS) requires an annual license for Trialtrove. Trialtrove's curated trial database will provide NCATS with cutting edge knowledge to provide an advantage to its curation and research efforts. This will enable researchers to extract key protocol details; including study objectives, endpoints, and inclusion/exclusion criteria; monitor trials throughout their life cycle; gain insights into trial timing benchmarks, enrollment successes and failures, accrual details, and study results including trial outcomes and biomarker tags. Trialtrove is the only product in this space that permits data reuse and distribution, which is crucial in allowing NCATS to use the information it accesses in the intended way: to leverage up-to-date clinical trial information to better inform the public of clinical candidates currently in development.

SPECIFIC REQUIREMENTS:

The vendor shall provide a software that provides the following:
1. Access to clinical trial metadata and intelligence including:
a. Key protocol details, including study objectives, endpoints and inclusion/exclusion criteria
b. Monitored trials throughout their life cycle
c. Trial timing benchmarks, enrollment successes and failures, accrual details and study results including trial outcomes and biomarker tags.
2. Access for 5 NCATS users

Period of Performance: One year license

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Cox Subscriptions, Inc. is the only vendor in the marketplace that can provide the products required by NCATS.

The intended source is:
Cox Subscriptions, Inc.
201 Village Rd
Shallotte, NC 28470

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95023Q00495NOI. Responses must be submitted electronically to Sarah Adan, Contracting Officer, at sarah.adan@nih.gov. U.S. Mail and fax responses will not be accepted.