Inactive

The U.S Army Medical Research Acquisition Activity (USAMRAA) in support of the Enterprise Information Technology Project Management Office (eIT-PMO), is seeking information in the form of capabilities... The U.S Army Medical Research Acquisition Activity (USAMRAA) in support of the Enterprise Information Technology Project Management Office (eIT-PMO), is seeking information in the form of capabilities statements for providing Oracle Argus Safety software support for an existing license. ***This requirement is for Software Support Renewal for an existing Argus license install base*** System for Award Management (SAM) registration is mandatory (www.sam.gov). It is anticipated that the type of contract will be a Firm Fixed Price. This 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 employee’s 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. Responses to this RFI shall include the appropriate contract vehicle information, such as type of contract vehicle, business size, NAICS Code. This RFI is for fact finding and planning purposes only. You are encouraged to inform the Government of any barriers that would prohibit them from competing. A listing of minimal essential characteristics (MECs) is listed below. The Government reserves the right to decide whether or not a small business set-aside is appropriate based on responses to this notice. 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, DUNS, 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.); (5) Indicate which NAICS code(s) your company usually performs under for Government contracts; (6) Information pertaining to any GWACs, IDIQs, or other contract vehicles where your company sells product(s) that can meet the MECs. MECs: All product software shall be capable of being installed and configured in such a manner as to remain in compliance with Department of Defense (DoD) security standards. All product software shall have a compatible version that supports installation and can be maintained on current Operating Systems within Department of Defense networks. The current minimum requirement is Microsoft Windows Server 2019. Software compatibility to function on Department of Defense networks shall be considered a high priority effort. Any mandatory pre-requisite software for each product shall be maintained at a version currently supported by the pre-requisite software vendor, i.e. MSXML, Java, .Net Framework. Help clinical research organizations collect, code, analyze and report adverse events, as well as meet regulatory reporting deadlines and global requirements. Speed information delivery, prevent delays, and provide visibility into work-in-process and due dates. Provide automated delivery of reports to recipients based on case characteristics, product identity, and recipient requirements resulting in timely, accurate, and flexible regulatory compliance. Enable users to meet deadlines through its support of general-case lists reports, blinded reports, and periodic reporting requirements for line listings of events and as well as detailed analysis of the impact of new findings on the safety profile of the product in an automated and coordinated manner. Provide a fundamental building block for efficiently capturing and managing adverse event report data across the full product life cycle from clinical development through post-marketing. Can deliver a powerful and complete platform for companies to realize the benefits of proactive. pharmacovigilance and risk management when combined with advanced techniques such as data mining, data visualization, and signal detection and management products. The software must support Microsoft Windows 2019 (64-bit) operating system. The software must be able to perform authentication using Public Key Infrastructure, (PKI), such as DoD Common Access Card (CAC) or DoD External Certificate Authority (ECA). Must be compliant with Title 21 of the Code of Federal Regulations (CFR), Part 11 requirements. The Oracle Argus software license maintenance must meet the following sustainment requirements: A. Technical Assistance (online/phone support) with development engineers and customer support specialists during standard normal business hours (7 AM to 6 PM) workdays (Monday- Friday) as long as the product is being used by the Army. B. Feature enhancements and new product releases C. Security patches and fixes D. Provide recommendations specific to our configuration E. Technical Resources, alerts and proactive support tools If your company is capable of providing the requirements described in the MECs, please provide a Capability Statement to Brandon Clingan at james.b.clingan.civ@health.mil Please do not respond with generic material only such as brochures or advertisements. A response to this RFI must be provided no later than (NLT) 12 March 2024 at 12:00 PM Eastern Time. No extensions will be granted. THIS IS NOT A SOLICITATION ANNOUNCEMENT OR REQUEST FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT.