Trialtrove Software Statement of Work (2026-09-23).docx

SOLICITATION NO. 7571TE26P00155

Attachment #1

1.1 Statement of Work / Performance Work Statement / Specifications

1.1.1 Background

This procurement is needed to support the immediate operational and regulatory oversight needs of the U.S. Food and Drug Administration (FDA). The acquisition directly supports the Department of Health and Human Services (HHS) initiative, Operation Trialblazer, which was launched on June 22, 2026, to accelerate first-in-human studies and secure America's leadership in biomedical research. A core component of this initiative is the FDA's new expedited IND Pilot Program.

To successfully execute and measure program progress, the FDA must have a reliable tool to map the global landscape of early-stage clinical trials and track our regulatory improvements in real time. FDA currently lacks access to a data source that can provide the necessary global clinical trial intelligence. While the agency utilizes ClinicalTrials.gov, this public registry has major limitations that make it insufficient for our current strategic goals. Specifically, ClinicalTrials.gov is heavily focused on U.S. data, suffers from incomplete participation, contains incomplete records for early-stage clinical trials, and experiences significant lag times in posting new information.

1.1.2 Objective

The objective is to establish a new contract for FDA/CDER user subscription licenses to Trialtrove+--a robust database of worldwide clinical trial data inclusive of early-stage clinical trials.

1.1.3 Scope

The Contractor shall provide the following:

· Trialtrove+ comprehensive datasets, curated by expert analysts for relevance.

· Using historical trial data, view Clinical Trial Trends.

· View Trial Activity Landscape by disease, sponsors, drugs, patient segment and country.

· Trialtrove+ built-in chat assistance and Ready-to-Use library prompts.

· ICD-10 mapping to identify trials by diagnostic codes.

· Availability of TrialTrove’s “Ask the Analyst” assistance.

· Study activity metrics including study start up insights by country, therapeutic area, disease and patient segments.

· Benchmark enrollment performance including patients per site per month and enrolment rates by country, therapeutic area, disease and patient segment.

· View screen failure metrics by country, therapeutic area, disease and patient segment.

· Monthly metrics from Citeline on FDA use of Trialtrove+ by users.

· Maintenance and technical support via email and/or web conference.

· Provide two one-hour training sessions that can be recorded by FDA.

· Access to online training material in Trialtrove+ resources.

2.0 PRICING AND CONTRACT TYPE

12 months

Two weeks after award and six weeks after first training completed.

10 business days after close of the previous month.

Total Evaluated Price: $87,000 Contract Type: Firm-Fixed Price

2.1 PERMITTED USES

The following are permitted uses of TrialTrove+ under FDA’s subscription.

Internal FDA Use Internal use of TrialTrove+ and the information made available or obtained from TrialTrove+ may be displayed, reformatted, and distributed internally within FDA, including integration within internal systems, for analysis, reporting, planning, research, and other related work, in the ordinary course of FDA's business.

Basic AI Permitted Use FDA may use TrialTrove+ and its underlying data as an input data set for an FDA AI Tool (defined below) solely for purposes of data summarization, augmented search, categorizing, and structuring data in furtherance of FDAs internal permitted use.

“FDA AI Tool” shall mean any FDA non-public artificial intelligence tools (i.e. the source codes are not publicly available) that utilizes a database containing non-public data in which the FDA owns, licenses, or otherwise has permissible access wherein such data is not available through open inquiry or available to third parties, and a public database such as PubMed and clinicaltrials.gov. By way of example, an FDA AI Tool could include a business or enterprise application of OpenAI ChatGPT, Gemini, Claude, or Microsoft Co-Pilot.

Except those uses described above, all other uses of TrialTrove+ are expressly prohibited. For avoidance of doubt, FDA shall not develop or train on any third party technology, artificial intelligence or machine learning, algorithms, or models using data obtained from TrialTrove+.

2.2 ADVANCED UNDERSTANDINGS

3.0 INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed by the FDA COR at FDA, White Oak, Maryland. The commercial inspection and acceptance terms in FAR 52.212-4 apply unless an authorized deviation or tailored term is included in this solicitation.

The Government shall have seven (7) business days after receipt of login credentials to TrialTrove+ to inspect and verify that the subscription is operational, functional, and compatible with FDA server and software.

4.0 DELIVERY OR PERFORMANCE