B01 - RFI Sources Sought.pdf

Subject: Arbovirus Epidemiological Studies in Southern Thailand for United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD - AFRIMS)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ);

IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS

NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO

CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

1.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

2.0 SUBJECT: The purpose of this requirement is to provide services associated with scientific/technical, regulatory, clinical, epidemiological, laboratory, administrative, database management, quality assurance, and logistical support required for the execution of prospective arbovirus epidemiological studies, conducted in Southern Thailand.

Southern Thailand is a US-personnel restricted area. Epidemiological information from Southern Thailand has considerable gaps. This region is of significant interest due to its location, and the proximity and cross border traffic with Malaysia. Most of Southern Thailand is rural with many of the inhabitants outside the city center, working in the agricultural field and continuously exposed to mosquito vectors.

3.0 BACKGROUND: The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

The United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMDAFRIMS) is an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR).

AFRIMS has programs in Enteric Diseases (infectious causes of diarrhea), malaria vaccine and drug research, viral diseases, an Entomology department dedicated study of disease vectors and the Retrovirology department which has been organized to execute vaccine studies for the HIV-AIDS virus.

4.0 RESPONSE INSTRUCTIONS: Respondents should address the following in their capabilities statement:

The objective of this requirement is to provide services associated with scientific/technical, regulatory, clinical, epidemiological, laboratory, administrative, database management, quality assurance, and logistical support required for the execution of prospective arbovirus epidemiological studies, conducted in Southern Thailand.

Specific Tasks / Requirements

1. Provide the following services:

1.1. Conduct projects in accordance with the prescribed protocols, current or amended as may be available and approved by international and local regulatory authorities.

1.2. Collaborate on the execution of the protocol with the USAMRMC, local Regulatory

Authorities, USAMD-AFRIMS, and local collaborators, stakeholders and communities.

1.3. Design, develop, deploy, and maintain relational database management system according to procedures and approved protocols.

1.4. Provide services of a principal clinical investigator for studies, planning and executing the projects and managing associated documents and data.

1.5. Provide support with the interpretation, compilation, analysis, presentation and publication of study results.

1.6. In coordination with AFRIMS, submit to all relevant Ethical Committees (EC) or

Institutional Review Boards (IRB) all study-related material, respond to their queries and obtain approvals.

1.7. Provide Clinical and Epidemiological Services. Procure services provided by qualified medical and epidemiological staff (i.e. physicians, nurses, allied health professionals, and others) that will be best suited to meet project requirements for subject recruitment and enrollment, intervention, if applicable, maintenance of study-related documentation (i.e. ICF, CSF and others), clinical and epidemiological evaluations, specimen collection, processing, storage and shipping, data gathering, and data management, logistical and administrative support, among others. Clinical assessments rendered may include vitals sign measurements, physical examinations, adverse event reports and other clinical evaluations as needed.

1.8. Provide services as outlined in the protocols for community and schools engagement, study advertisement, screening and recruitment, clinical management, enrollment, demographic/clinical data and sample collection of enrolled subjects (i.e., obtaining informed consent/assent, medical history, performing physical examination, inclusion/exclusion assessment, immunization, follow-up of subjects and completion of case report form, phlebotomy, ultrasound) and initial laboratory testing.

1.9. Purchase supplies and reagents needed to support AFRIMS projects and guarantee their delivery as requested by AFRIMS.

1.10. Provide administrative, accounting, and financial services including reimbursement to study volunteers for attending study-related activities to support daily operations.

1.11. Provide the necessary monetary advances and ultimate reimbursement for staff official travel expenses, as approved by study PI.

1.12. Process payment for any study related fee, translation, IRB-related, facilities use, licensing and permits in order to accomplish the tasks in accordance with local legal requirements for the activities as well as specimens being collected, transferred and/or sent.

1.13. Provide storage space for document and supplies during the duration of a trial.

1.14. Maintain files (electronic and hardcopy) for work products (including all clinical protocol associated documents), associated reference material, and data for the duration of the contract. Develop, implement, and maintain a database (or catalogue) of files accessible and reportable to the government (and government designees upon notification from the COR) relevant to the projects.

2. Collect, manage and provide clinical, demographic and epidemiological data from study subjects as described in the approved protocols, in a form that is required by study-related forms, as described above.

2.1. Collect, process, and store biological specimens (i.e., blood, PBMCs, urine, and others as relevant) collected from enrolled subjects during the execution of a study protocol. Ship biological specimens to AFRIMS for storage, and testing and/or to the U.S. for further testing accordance with approved protocols or as part of USAMD-AFRIMS public health services. Provide local or international transportation including data/supply/specimen shipment in-out of the country. Regularly, or on request, coordinate with participating hospitals, health centers or study sites and AFRIMS for the specimens’ collection and transfer; providing temperature controlled storage before and during transportation of samples to AFRIMS.

2.2. Conduct Laboratory Testing. Procure services provided by qualified laboratory and technical staff (i.e. medical research technologists, technicians, microscopists, and laboratory workers) that shall best suit project requirements for laboratory assessments required to support study activity. Assessments rendered may include complete blood counts, chemistries, urine testing, immunological and diagnostic assays, clinical microscopy and other lab tests as required.

2.3. Provide Transportation and Communications. Procure transportation support for personnel and non-personnel resources by whatever conveyance is required to meet project needs. Procure communications services and support to meet project needs.

2.4. The Contractor shall attend the annual face-to-face meeting with AFRIMS Virology.

Provide venues adequate for meetings or training events which are attended by AFRIMS personnel, or personnel from clinical site and others. Provide travel related to site visits/meetings, training, conferences, workshop, and presentation in support of this contract.

2.5. Provide training for personnel involved in the studies in order to implement studies to ensure compliance with requiring institutional class or on-line training and other trainings required by AFRIMS, the sponsor or assigned CRO (clinical research organization).

2.6. Establish internal standard operating procedures (SOPs) to ensure oversight on the proper conduct of the biomedical surveillance and study projects to continually improve and ensure uninterrupted, timely, and efficient conduct of the study by providing the necessary continuous quality assurance systems.

5.0 CONTACT INFORMATION: Any and all questions related to this RFI shall be directed to Ms.

Ashley Atkins at ashley.n.atkins.civ@mail.mil. All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to ashley.n.atkins.civ@mail.mil no later than 08:00 a.m. E.S.T. on Tuesday, 06 April 2021.

Specific Tasks / Requirements