Research Information Technology Capabilities for USAMRDC eIT PMO

The U.S Army Medical Research Acquisition Activity (USAMRAA) in support of the Enterprise Information Technology (eIT) Project Management Office (PMO) is seeking information in the form of capabilities statements from vendors with the potential to fully meet the requirements of the PMO. System for Award Management (SAM) registration is mandatory (www.sam.gov). It is anticipated that the resulting contract will be an Indefinite Delivery Indefinite Quantity (ID/IQ) contract that will potentially include a combination of Firm Fixed Price and Cost-type support. This Request for Information (RFI) is issued for informational and planning purposes only. Contact with Government personnel, other than those specified in the RFI, by potential vendors or their employees regarding this requirement is not permitted. This is not a Request for Proposal (RFP). It is not to be construed as a formal solicitation or an obligation on the part of the Government to acquire any products or services. The information requested by this RFI will be used within USAMRAA to facilitate decision making and will not be disclosed outside of USAMRAA. Any information provided to the Government is strictly voluntary and will be provided at no cost to the Government. This RFI is for fact finding and planning purposes only. You are encouraged to inform the Government of any barriers that would prohibit your company from competing. This RFI is in support of the eIT PMO's service focused, project management and acquisition strategies group, providing direct acquisition/Life Cycle Management support to the Sub-portfolio level and below, while providing indirect support to the project level. A draft Performance Work Statement (PWS) is attached. The draft PWS is subject to change prior to a formal solicitation release. The Government reserves the right to decide whether or not a small business set-aside is appropriate. Small businesses are reminded that under a small business set-aside, the contractor will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated, in accordance with FAR 52.219-14 Limitations on Subcontracting. If the information provided contains propriety information, such information must be identified with appropriate disclaimers. At a minimum, the following additional information is requested: (1) Capability Statement; (2) Company Cage Code, SAM Unique ID, SAM registered name, address, point of contact and their telephone number and e-mail address; (3) Approximate annual gross revenue; (4) Any small business status (8(a), HUB Zone, veteran-owned, women-owned, etc.); and (5) Indicate which NAICS code(s) your company usually performs under for Government contracts. You are encouraged to submit the following highly desirable information in response to this RFI, demonstrating your company's ability to provide the following: a. The Capability Statement should include general information and technical background describing your company's experience within the last five years, specifically with Federal Government or commercial market contracts similar in scope, complexity and size to meet the program objectives in accordance with the draft PWS. The Capability Statement should describe your company's experience supporting/staffing multiple projects at various stages within the life cycle while concurrently responding to multiple stakeholders. b. Expert ability to enable and support the full acquisition life cycle of each project through proven project management practices utilizing known standards, best business practices, and timely resource management. Additionally, conform to Department of Defense (DoD), Army, and Defense Heath Agency (DHA) records management requirements. This support shall include all necessary activities required to execute the functions of an Acquisition Project Management Office (PMO) delivering and sustaining multiple IT products. The personnel must be able to integrate commercial best practices to the DoD policy, understanding the restrictions created from being a government organization. c. Demonstrated and expert capability in Laboratory Information Management Systems (LIMS) and informatics strategy, to include technology and data strategy, competency in Department of Defense Architecture Framework (DoDAF) or similar DoD architectures. This should include your company's ability to produce overviews, as required, conforming with Government directed DoD architecture framework standards and polices, implementation and deployment, master data, and validation in regulated environments, with at least five past performances for commercial and federal contracts within the last five years. d. Demonstrated and expert ability to conduct organization change management and training in respect to informatics deployments and scientific or clinical systems such as Electronic Data Capture (EDC), Electronic Common Technical Documentation (eCTD), Serious Adverse Event (SAE) Reporting Systems, and/or Electronic Document Management System (EDMS), including expertise in design, deployment, and continuous development of medical research Opentext document management and workflow management system of similar size and scope. e. Demonstrate and provide experience in the areas of Federal Drug Administration (FDA) regulatory submission and technical management of systems and/or capabilities conforming to the standards in CFR 21 Part 11. Additionally, demonstrate experience with audit readiness and rigor in electronic documentation using both GAMP5 and other governing regulatory bodies to ensure the project or projects meetings audit compliance. f. Demonstrated expertise is the areas of DoD Adaptative Acquisition Frameworks with focuses on Defense Business Pathway (DoDI 5000.75), Software Acquisition Pathway (DoDI 5000.87) and Major Capability Acquisition pathway, including performance of at least two of the three acquisition pathways. g. Established vendor partnerships across clinical, regulatory, and informatics to enable successful downstream delivery, leveraging your company's ability to proactively define follow-on system capability, seek efficient and effective systems integration and expansion where practical. h. Capability to provide specific subject matter expertise consultation for informatics, Life Sciences and R&D, with an available resource pool across each domain space comprised of clinical, informatics, and regulatory personnel. i. Demonstrated experience working with a complex vendor ecosystem across clinical, regulatory, and informatics with expert knowledge in scaling laboratory informatics technologies across business units, regionally or globally. j. Expert ability to integrate across various hardware, software and hybrid technologies. Areas include Oracle based solutions, Windows and Linux operating systems, multiple COTS products, different types of infrastructure services and various middleware across systems. Additionally, demonstrate experience with IT infrastructure and architecture development to include modernization, network expansion, enterprise services and overall sustainment and maintenance. k. Demonstrated capability in navigating mid to large DHA programs in the last five years, with expertise in laboratory and quality assurance system implementation, regulatory policies and procedures, Risk Management Framework and cyber hygiene, and project management approaches and practices. l. Ability to provide support in budgetary matters. Ability to assist in the staffing of Program Objective Memorandums (POM), strategic DHA enterprise-wide group purchases, and the associated coordination activities between DHA directorates involving Planning, Programming, Budgeting & Execution (PPBE). m. Demonstrate ISO 9000 and/or CMMI Level 3 (or above) current certification and/or current equivalent certifications. Responses must be provided no later than 13 June 2023 at 10:00am Eastern Time. No extensions will be granted. Responses shall be submitted via email to the USAMRAA Point of Contacts, Ms.Tara Borntreger at tara.j.borntreger.civ@health.mil and Mr. Jeremy McMurry at jeremy.l.mcmurry.civ@health.mil. Only electronic responses will be accepted. Please do not respond with generic material only such as brochures, advertisements or other generic material.