NIH RFQ: Electronic Quality Management System (eQMS) and Electronic Trial Master File (eTMF) for NIAID

The purpose of this requirement is to determine and prioritize functional and technical requirements that meet the regulatory and compliance needs of the National Institute of Allergy and Infectious Diseases (NIAID) Intramural and Extramural Divisions and to understand the technology system and tool landscape for electronic Quality Management systems (eQMS) and electronic Trial Master Files (eTMF). Specifically, NIAID is seeking:

  • Commercial off-the-shelf (COTS) eQMS that can scale to support multiple divisions within NIAID.
  • COTS eTMF that can scale to support multiple divisions within NIAID.
  • Professional services to configure, deploy, train, validate, migrate existing documents, and support NIAID’s use and adoption of the eQMS and eTMF systems.
  • Ongoing support including maintaining compliance with changing regulatory requirements and mitigation of security vulnerabilities…

The Contractor shall provide:

  1. Licenses must be provided for an enterprise solution capable of supporting all NIAID divisions within the Institute as well as external NIAID partners, CROs, and other collaborators.
  2. A System with no dependencies, restrictions, or limitations on the number of trials, protocols, documents, workflows, or other entities managed by the System.
  3. Licenses must be offered in increments of 25 with discounts increasing along with total license count. NIAID expects the total license count to increase to approximately 200 within five years.
  4. Licenses must not be required for:
    1. NIAID System Administrators and helpdesk support staff
    2. Development, QA, or Training environments
  5. Licenses and support periods of performance will become effective and payment will be due upon NIAID’s acceptance of the System Release Memo…

Read more here.

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