SOURCES SOUGHT
A -- Clinical Trial Support Services - Attachments
- Notice Date
- 6/7/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH180316RFI-REV
- Archive Date
- 7/4/2018
- Point of Contact
- Julie L. Burns,
- E-Mail Address
-
julia.l.burns3.civ@mail.mil
(julia.l.burns3.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Attachment 3 - DRAFT Statement of Objectivities Attachment 2 - Capabilities Template Attachment 1 - Questions to Vendors Request for Information (RFI) Clinical Trial Support Services 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. Disclaimer: The purpose of this RFI notice is to gain market knowledge. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities at https://www.fbo.gov at a future date and time. However, responses to this notice will not be considered adequate responses to a solicitation. 1. RFI Number: W81XWH180316RFI-REV 2. RFI Issuing Office: United States Army Medical Research Acquisition Activity (USAMRAA) 3. RFI Issue Date: 07 June 2018 4. RFI Title: Clinical Trial Support Services (non-Personal services) 5. Agency (ies): United States Army Medical Research and Materiel Command (USAMRMC) / Walter Reed Army Institute of Research (WRAIR) 6. Office: Clinical Trials Center (CTC) 7. Location: Silver Spring, MD 20910 8. Contract Type: Single Award Indefinite Delivery/indefinite Quantity (ID/IQ), Hybrid Cost Plus Fixed Fee (CPFF) / Firm Fixed Price (FFP) 9. Synopsis: In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchanges With Industry Before Receipt of Proposals" and FAR 52.215-3, "Request for Information or Solicitation for Planning Purposes" this Request for Information (RFI) is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of the USAMRAA, USAMRMC, or WRAIR. This RFI is for information and planning purposes only and is neither to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents are solely responsible for all expenses associated with responding to this RFI. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. If a solicitation is released it will be synopsized on FedBizOpps (FBO) at https://www.fbo.gov. It is the responsibility of any potential Offeror to monitor this site for the release of any solicitation or synopsis. 10. Background: The Walter Reed Army Institute of Research (WRAIR) is the largest and most diverse biomedical research laboratory in the Department of Defense. Our main facility, the Daniel K. Inouye building, is located in Silver Spring, Maryland. Other laboratory and clinical facilities carry out research in Asia, Africa, and Europe through cooperative partnerships with host governments and militaries through the US State Department. Our greatest resources are the dedicated scientists, technicians, and support personnel who make up the core of the WRAIR today. The Clinical Trials Center (CTC) was established as a clinical research unit in early 1992 to support Army and Navy investigators in their mission to develop new vaccines, drugs and diagnostics systems that will benefit not only the military, but all people. An average of 13-15 clinical studies are annually conducted by the CTC. To implement these studies, the CTC enrolls over 350 volunteers per year. By integrating basic research and advanced technology for the primary goal of protecting the Warfighter, the WRAIR serves as the premier biomedical research organization within the Department of Defense. The Institute hosts both the Centers for Infectious Disease Research and Military Psychiatry and Neuroscience Research. With headquarters in Silver Spring, Maryland, laboratories are also hosted in subordinate directorate locations in Washington State, Thailand, Germany, the Republic of Georgia and Kenya. The CTC is physically situated at the WRAIR to conduct clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP). All of the work to support this research must be performed in accordance with the Federal, Department of Defense (DOD), and Command laws, regulations, and policies. Clinical research studies require production of experimental products, approved research protocols, laboratory analysis of samples, analysis of resulting data, and submission of study findings to appropriate sponsors and stakeholders. Vendor capabilities must meet or exceed the specifications detailed in Objectives 1 - 16 of the Statement of Objectives (Attachment 3). 11. Objective and Purpose/Scope: The purpose of this RFI is to identify vendors with Clinical Trial support services capabilities. The scope of this requirement shall be to implement all aspects of clinical trial activities in compliance with human subjects' protection regulations and to support a level of quality that will result in successful regulatory submissions for product development. 12. North American Industry Classification System (NAICS) Code: The NAICS code is 541715 "Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)" with a Size Standard of 1,000 employees. 13. RFI Attachments: The following documents are attached to this RFI: i. Questions to Vendors (RFI Attachment 1) ii. RFI Capabilities Statement (RFI Attachment 2) iii. DRAFT Statement of Objectives (RFI Attachment 3) 13.1. Questions to Vendors (RFI Attachment 1). As part of your RFI response, please address the questions in Attachment 1. The attached is for information and planning purposes only. 13.2. RFI Capabilities Statement (RFI Attachment 2). As part of your RFI response, please complete the Capabilities Statement. The attached is for information and planning purposes only. 13.3. RFI Statement of Objectives (RFI Attachment 3). As part of your RFI response, please review and provide feedback on the Government's DRAFT SOO. The attached is for information and planning purposes only. 14. Response Due Date: Interested parties shall submit the RFI response electronically by 1 :00 pm Eastern Tuesday, 19 June 2018 via e-mail to: Julie L. Burns julia.l.burns3.civ@mail.mil 15. Instructions to Respondents: 15.1. The Government appreciates responses from ALL capable and qualified sources. 15.2. Interested firms should submit a response that demonstrates the Respondent's ability to perform the scope of work identified in this RFI. 15.3. Format specifications include Arial 12-point font, single spaced, single sided, 8.5 by 11-inch paper with 1-inch margins. All submissions shall be made electronically (as described above) and be in one of the following formats: Microsoft Word or searchable Adobe PDF. 16. Confidentiality: All 'Proprietary', 'Classified', 'Confidential', or 'Sensitive' information shall be marked as such, and will be treated accordingly. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). (End of RFI)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH180316RFI-REV/listing.html)
- Place of Performance
- Address: Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN04947363-W 20180609/180607230810-4099ef902dfc7ee1ee6ce5a4315c4218 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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