NOTICE OF INTENT TO SOLE SOURCE – COMBINED SYNOPSIS/SOLICITATION - Trialtrove+ Subscription

The Department of Health and Human Services Office of the Assistant Secretary for Administration seeks a sole-source purchase order for Citeline Trialtrove+ subscription services supporting the FDA's Operation Trialblazer initiative, with responses due September 25 at 3:00 PM Eastern Time and questions due September 24 at 10:00 AM EST. The procurement is an unawaarded sole-source intent, with the contracting officer determining Caerus US 1 Inc. as the sole source capable of providing the required Citeline subscription and data services.

Place of performance is Rockville, VA 23146. The FDA requires 30 user subscription licenses for a 12-month period from September 30, 2026 through September 29, 2027. The NAICS code is 513210, Software Publishers; PSC code R612, Support—Administrative: Information Retrieval. The evaluated price is $87,000 on a firm-fixed-price basis.

Deliverables include access to Trialtrove+ datasets with expert curation, clinical trial trend analysis, trial activity and enrollment benchmarking metrics, screen failure data, and ICD-10 mapping capabilities. The contractor must provide two one-hour recorded training sessions (one within two weeks of award, one within six weeks after initial training), maintain technical support via email and web conference, and submit monthly usage reports. Permitted uses are limited to internal FDA operations and basic AI applications for data summarization and categorization within FDA non-public tools; development or training of third-party AI systems using Trialtrove+ data is expressly prohibited. The government has seven business days after receiving login credentials to inspect and verify operational functionality. Capability statements must not exceed five double-spaced pages and include company information, UEI, CAGE code, business size, proposed product description, evidence of meeting requirements, identification of material differences from Citeline products, pricing, and point of contact. The quotation validity period is 30 days. The government reserves the right to proceed with the sole-source award or conduct a competitive procurement based on responses received.