ELECTRONIC TRIAL MASTER FILE (ETMF) TRIAL INTERACTIVE SOFTWARE-AS-A-SERVICE FOR CLINICAL STUDIES
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SUMMARY
DESCRIPTION
The National Institute of Allergy and Infectious Diseases (NIAID) intends to award a sole source, firm-fixed price bridge contract to TransPerfect Translations International, Inc. for the provision and support of the Trial Interactive electronic trial master file (eTMF) software. This contract covers the continued use and maintenance of TransPerfect’s Trial Interactive application for NIAID clinical divisions, including the Vaccine Research Center, to support clinical document management needs.
The scope of services includes software licensing, system configuration to NIAID’s requirements, end-user training, and ongoing technical support for at least four active clinical research protocols. This eTMF solution ensures that essential clinical trial documents are maintained in an inspection-ready, validated system, supporting NIAID’s obligations as a clinical research sponsor. The contract has a performance period from March 2, 2026, to December 3, 2026, with the option to increase licenses and services to accommodate additional studies if necessary.
This acquisition is being pursued under the authority permitting sole source awards when only one responsible source can fulfill the agency's requirements. The applicable NAICS code is 513210 (Software Publishers). Interested organizations with the ability to meet these requirements may submit a capabilities statement for consideration regarding future competitive actions.
Source attribution
This Settle analysis is based on the issuing organization’s public RFP listing.