Electronic trial master file (etmf) trial interactive software-as-a-service for clinical studies

This is a Notice of Intent (NOI). This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 253 (c)(1), as implemented by FAR 13.106-1(b) and 13.501(a)- Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for quotes.

The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate on a sole source basis with TransPerfect Translations International, Inc., 1250 Broadway, FL 7, New York, NY 10001-3749.    This acquisition will be to establish a bridge contract to maintain TransPerfect’s Trial Interactive electronic trial master file (eTMF) software to continue providing support for clinical document management for the National Institute of Allergy and Infectious Diseases (NIAID) clinical divisions as the Vaccine Research Center. TransPerfect will continue to deliver support for the Trial Interactive software implementation and end-user training for NIAID staff to manage their Trial Master Files electronically. Services include configuration of the application to fit the requirements of NIAID clinical divisions staff support clinical trials. The Trial Interactive application will be implemented for at least four ongoing research protocols. This application is vital to ensure that essential documents from clinical trials are captured in an inspection-ready system that supports NIAID’s responsibilities as a sponsor or clinical research. NIAID requires the procurement of Trial Interactive licenses and TransPerfect support services to continue to provide eTMF capabilities for a 6-month period, with the option to expand the number of licenses and support services for additional studies if needed.    Period of Performance: March 02, 2026 – December 3, 2026. The North American Industry Classification (NAICS) code for this acquisition is 513210 Software Publishers, which has a size standard of $47.0 million. TransPerfect is an other than small business. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement.  The Government plans to award a contract for this requirement within 8 days of this notice. While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement.  The Government understands that TransPerfect is the only vendor who can provide the requested services for NIAID.  However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within 8 days after publication of this notice.  Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.  Interested parties may identify their interest and capability to respond to the requirement or submit offers on NOI-NIAID-26-2281689. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response.  The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.  Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.  Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Linda Smith, Contracting Officer at Linda.smith2@nih.gov