SB RFI: CLINICAL STUDIES AND HEALTH SYSTEMS APPLICATIONS SUPPORT

Request for Information (RFI) The Defense Health Agency (DHA), is seeking information in the form of capabilities statements and availability from capable small business contract holders only. Only submissions by small businesses will be accepted by the Government. Any submission by a contractor that is not a small business will not be considered for this RFI. In an attempt to promote full and open competition and seek competitive quotes, USAMRAA is issuing a Request for Information (RFI) to seek small businesses under the North American Industry Classification System (NAICS) Code - 541990 All Other Professional, Scientific, and Technical Services. System for Award Management (SAM) registration is mandatory (www.sam.gov). It is anticipated the type of contract will be a Firm Fixed Price. 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/DHA to facilitate decision making and will not be disclosed outside of USAMRAA/DHA. 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. The information will be used in conducting market research to identify qualified, experienced, and interested potential small business sources in support of the Government's requirements in accordance with the attached DRAFT Performance Work Statement (PWS). 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 based on responses to this notice. Contractors are encouraged to inform the Government of any barriers that would prohibit them from competing. Contact with Government personnel, other than those specified in the RFI, by potential offerors or their employee's regarding this requirement is not permitted. Responses to this RFI shall include the appropriate contract vehicle information, such as type of contract vehicle, business size, NAICS Code. At a minimum, the following information is requested: (1) Capability Statement, (2) Company Cage Code, DUNS, CCR registered, name, address, point of contact and their telephone number and e-mail address; (3) Any small business status (8(a), HUB Zone, Service Disabled Veteran Owned Small Business (SDVOSB), women-owned, etc.); (4) Indicate which NAICS code(s) your company usually performs under for Government contracts. Vendors are encouraged to submit the following highly desirable information in response to this RFI: Please describe or provide examples of your ability to facilitate writing and development of clinical studies protocols, as well as perform recruitment, enrollment, specimen collection, handling, and shipment; collect, analyze, and interpret data; and all other activities required in order to execute vaccine safety, effectiveness, and acceptability studies within the Military Health System (MHS), or other large civilian, research, or academic medical centers. Be specific about the scope of your support and your role (Prime vs Subcontractor). Please describe or provide examples of your ability to perform all regulatory tasks related to clinical studies protocols. For example, please demonstrate your company's experience with writing and submitting protocols, continuing review reports, reportable event forms, consent forms, HIPAA authorizations, Data Sharing Agreements, Business Agreements, and other relevant clinical studies and regulatory submissions. Be specific about the level of Government sponsor(s), Government staff participating, methodology used and tasks completed, impact to the organization, and your role (Prime vs Subcontractor). Please describe your company's ability to plan, define, develop, revise, and implement existing healthcare information management systems, equipment and services to benefit the Immunization Healthcare Division. Please describe or provide examples of your ability to provide secure solutions to complex data management and reporting challenges, including but not limited to, creating data forms, clinical data tracking systems, development of online survey distribution tools, etc. Be specific about the level of Government sponsor(s), Government staff participating, methodology used and tasks completed, impact to the organization, and your role (Prime vs Subcontractor). Please demonstrate your company's ability to recruit, hire, and retain specialized, qualified clinical studies personnel who can carry out the tasks listed in the Performance Work Statement. Please provide specific examples of your ability to partner with non-profit organizations that are able to recruit more specialized scientific personnel such as Research Physicians, Nurse Practitioners/Physicians Assistants, skilled Clinical Research Nurse Coordinators, etc. Be specific about the level of Government sponsor(s), Government staff participating, methodology used and tasks completed, impact to the organization, and your role (Prime vs Subcontractor). Furthermore, your ability to team with subcontractors that can meet the unique staffing needs of this requirement, to include non-profit contracts. If your firm is capable of providing the requirements described in the DRAFT Performance Work Statement (PWS), please provide a Capability Statement to Ms. Chelsey Jahn at chelsey.n.jahn.civ@mail.mil. A vendor responding to this RFI with generic material only, such as brochures, advertisements or other generic material, is highly discouraged. No questions will be entertained at this time. Responses Responses to this notice are not offers and CANNOT be accepted by the Government to form a binding contract. Should your firm desire to submit a capability statement, it should demonstrate the Offeror's experience and expertise to provide the services identified in the draft PWS within the time frame required. Parties may begin submitting responses to this request for information immediately. If the information provided contains propriety information, such information must be clearly identified with appropriate disclaimers. Capability Statements in Microsoft Word for Office 2010 (or higher) compatible format are due no later than 19 November 2021 at 1:00 PM ET. RFI Responses shall be limited to ten (10) pages, not including cover and administrative pages and submitted via e-mail to Chelsey.n.jahn.civ@mail.mil. Responses shall be written using a 10 point font size or larger. Statements should not exceed 10 pages in length, excluding cover and administrative pages. The subject line of the email should read as follows - SB RFI: Clinical Studies and Health Systems Applications Support Maximum participation by small business, veteran-owned small business, service-disabled veteran-owned small business, HUB Zone small business, small disadvantaged business, and women-owned small business concerns is encouraged. THIS IS NOT A SOLICITATION ANNOUNCEMENT OR REQUEST FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT.