SOURCES SOUGHT
A -- Contract Research Organization for data-management, monitoring, and scientific writing support for the Diagnosis of Cutaneous Leishmaniasis in Peru
- Notice Date
- 1/22/2018
- 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 Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- ADVFY18RD00014
- Archive Date
- 2/28/2018
- Point of Contact
- Cheryl Vendemia, Phone: 3016196004, Thomas L. Hood, Phone: 3016199236
- E-Mail Address
-
cheryl.r.vendemia.civ@mail.mil, thomas.l.hood26.civ@mail.mil
(cheryl.r.vendemia.civ@mail.mil, thomas.l.hood26.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 (one responsible source) to Fast-Track Drugs and Biologics, LLC, 5 Paramus Court, North Potomac, MD 20878. The Naval Medical Logistics Command (NMLC) is seeking Contract Research Organization (CRO) sources with a large trajectory of research in Leishmaniasis for a collaborative research effort to provide data-management, monitoring, and scientific writing support for the study titled "Evaluation of a Diagnostic Device, CL Detect TM Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru" in support of Naval Medical Research Unit Six (NAMRU-6), Parasitology Department, Ave. Venezuela Cdra 36 s/n, Bellavista - Callao - Peru. The primary objective of the study is to determine the sensitivity and specificity of the FDA-cleared CL Detect TM Rapid Test in Peru, using a test procedure that was modified from that described in the device instructions to optimize these parameters for the detection of Leishmania species identified in Peru. The CL Detect TM Rapid Test is the trade name for the Cutaneous Leishmaniasis Rapid Diagnostic Device (LRDD). This acquisition requires the research project to provide data-management, monitoring, and scientific writing support for the study titled: "Evaluation of a Diagnostic Device, CL Detect TM Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru" (LRDD-PERU-02-NAMRU6.2015.0009). The CRO will perform activities such as developing study documents such as the Statistical Analysis Plan (SAP), Data-Management Plan, Monitoring Plan, Standard Operating Procedures (SOPs), Electronic-based Clinical Report Forms, Laboratory Manuals, and Logs (enrollment log, temperature log, device accountability log, temperature logs, etc.). The CRO will also provide onsite and remote monitoring, training for all study personnel, provide the template and assist with the regulatory compliance of the Trial Master File, organize frequent teleconferences with all study teams, and create and update the study database. Finally the CRO will be responsible for the data analysis according to the Statistical Analysis Plan, write the Clinical Study Report (CSR) and prepare scientific reports in collaboration with the investigators. All activities must be carried out with the utmost adherence to all ethical and quality control standards. The contract will have a performance period of 12 months. If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 to Fast-Track Drugs and Biologics, LLC, 5 Paramus Court, North Potomac, MD 20878. This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 9:00AM Local Time, 29 January 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: cheryl.r.vendemia.civ@mail.mil AND thomas.l.hood26.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/ADVFY18RD00014/listing.html)
- Place of Performance
- Address: Services to be performed at the contractor's facility in support of Naval Medical Research Unit Six (NAMRU-6), Parasitology Department, Ave. Venezuela Cdra 36 s/n, Bellavista - Callao - Peru., Bellavista - Callao, Peru
- Record
- SN04796222-W 20180124/180122231126-7bce07c20d5af740af794b3459be7012 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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