ELECTRONIC TRIAL MASTER FILE (ETMF) TRIAL INTERACTIVE SOFTWARE-AS-A-SERVICE FOR CLINICAL STUDIES
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institute of Allergy and Infectious Diseases (NIAID) has issued a Notice of Intent (NOI) to award a sole source, firm-fixed price purchase order to TransPerfect Translations International, Inc. for their Trial Interactive electronic trial master file (eTMF) software. This bridge contract will ensure continued support for clinical document management for NIAID's clinical divisions. Capabilities statements from interested vendors are due by February 28, 2026.
Scope of Work
This acquisition is for the maintenance of TransPerfect's Trial Interactive eTMF software, providing essential support for clinical document management. Services include software implementation, end-user training for NIAID staff, and configuration of the application to meet the specific requirements of NIAID clinical divisions. The Trial Interactive application will be deployed for at least four ongoing research protocols, ensuring that essential clinical trial documents are captured in an inspection-ready system.
Contract & Timeline
- Type: Notice of Intent (NOI) for a Sole Source, Firm-Fixed Price Purchase Order
- Intended Awardee: TransPerfect Translations International, Inc.
- Duration: 6-month period, from March 02, 2026, to December 3, 2026, with an option to expand licenses and support for additional studies.
- NAICS Code: 513210 Software Publishers (Size Standard: $47.0 million)
- Set-Aside: None (Sole Source, TransPerfect is an Other Than Small Business)
- Capabilities Statement Due: February 28, 2026 (8 days after publication)
- Published Date: February 20, 2026
- Anticipated Award: Within 8 days of this notice.
Evaluation
This is a Notice of Intent to award on a sole source basis, citing 41 U.S.C. 253 (c)(1) and FAR 13.106-1(b) and 13.501(a) due to only one responsible source. Firms believing they can fully meet the Government's requirement may submit a capabilities statement, including past performance, for evaluation. This will determine if the procurement can be conducted on a competitive basis.
Contact Information
For additional information or to submit responses, contact Linda Smith, Contracting Officer, at Linda.Smith2@nih.gov.