NIH RFQ: Electronic Common Technical Document (eCTD) Publishing and Reviewing Software

Updated July 22, 2021

Notice ID RFQ-2076690

“2.2 CURRENT STATE

The current system is used for the storage of final documents for submissions in the EDMS, compilation and publishing of eCTD INDs and Drug Master Files (DMFs), eCTD validation of submissions, archive of transmitted submissions packages in the EDMS, and the review of eCTD applications. The current EDMS in use for the eCTD is OpenText Content Server 10.5.

3 SCOPE

The scope of this procurement is to acquire, configure, deploy, validate, and support an eCTD System for use by NIAID and its partners in accordance with regulated clinical research requirements as set forth by applicable health authorities.

“4 SOFTWARE REQUIREMENTS…”

4.1.2 General

The Contractor shall provide a System that must:

  1. Be offered as Software-as-a-Service and/or cloud-hosted solutions. Systems designed to be installed on premise at NIAID’s computing facility will not be considered.
  2. Be an enterprise solution capable of supporting all Divisions within the Institute as well as external NIAID partners, CROs, and other collaborators.
  3. Be accessible from within and external to the NIAID network by employees and partners for a variety of tasks and user types.
  4. Support integration with NIAID specified Security Assertion Markup Language (SAML)-based identity providers to permit single-sign-on for NIAID staff. The System must also support native authentication for users without records in a SAML identity management provider.
  5. Support role-based access and permission management.
  6. Support role-based access to all functions and workflows.
  7. Include security features to restrict and report unauthorized access attempts.
  8. Maintain audit logs of all system activity and document changes.
  9. Support configurable metadata and naming conventions.
  10. Fully support current and new versions of Windows and Macintosh operating systems.
  11. Fully support current and new versions of Google Chrome on Windows and Macintosh, and Apple Safari, Microsoft Edge, and Microsoft Internet Explorer on their respective operating systems.
  12. Be Section 508 compliant, in a way that is efficient to develop, implement, test, and use by all members of the NIAID user community.
  13. Be Federal Information Security Management Act (FISMA) Moderate compliant. FISMA certification will be required prior to placing the system in production use. Federal Risk and Authorization Management Program (FedRAMP) certification is highly desirable but is not necessary.
  14. Include fully functional test environment that is configured identically to the production environment…”

“Article F.1 PERIOD OF PERFORMANCE

  1. The period of performance of this order is from date of award for 365 days; currently estimated September 22, 2021 through September 21, 2022.
  2. If the Government exercises its options pursuant to the OPTION PROVISION Article in Section H of this purchase order, the period of performance is estimated to increase as listed below: …”

“Option Year 1  September 22, 2022 – September 21, 2023
Option Year 2  September 22, 2023 – September 21, 2024
Option Year 3  September 22, 2024 – September 21, 2025
Option Year 4  September 22, 2025 – September 21, 2026…”

Read more here.


Posted May 24, 2021

Notice ID: SS-RML-2076690

The purpose of this requirement is to obtain commercial-off-the-shelf (COTS) Electronic Common Technical Document (eCTD) and Electronic Document Management System (EDMS) software system for the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). The eCTD and EDMS software system must be offered as Software-as-a-Service (SaaS) and/or managed cloud solution.

Specifically, NIAID is seeking:

  • A COTS eCTD compilation, publishing, validation, and review system that can scale to support multiple divisions within NIAID with appropriate security and access controls to prevent access to submissions and information between divisions
  • A COTS EDMS system that integrates with the eCTD system, can scale to support multiple divisions within NIAID, and employs appropriate security and access controls to prevent access to documents and information between divisions
  • Professional services to configure, deploy, train, validate, and support NIAID’s use and adoption of the new eCTD and EDMS systems
  • Technical support services to support the migration of existing eCTD submissions and their full lifecycles from the existing eCTD publishing system
  • Ongoing system support including maintaining compliance with changing regulatory requirements, software upgrades, computer systems validation, and mitigation of security

Read more here.

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