This Sources Sought opportunity from Department Of Defense was posted on January 22, 2018. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Contract Research Organization for data-management, monitoring, and scientific writing support for the Diagnosis of Cutaneous Leishmaniasis in Peru

Closed

ADVFY18RD00014Federal

Submission Closed01/29/2018, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

The Naval Medical Logistics Command is seeking a Contract Research Organization to provide data management, monitoring, and scientific writing support for a study evaluating the CL Detect Rapid Test for diagnosing Cutaneous Leishmaniasis in Peru. Supporting the Naval Medical Research Unit Six, the selected contractor will be responsible for developing essential study documentation, including Statistical Analysis Plans and Standard Operating Procedures, while providing onsite and remote monitoring, personnel training, and database management. The project concludes with data analysis and the preparation of a Clinical Study Report, all conducted under strict ethical and quality control standards over a 12-month performance period. This sources sought notice serves to determine if competitive sources exist; otherwise, the government intends to award a sole source contract to Fast-Track Drugs and Biologics, LLC. Interested parties must submit a one-page capability statement detailing their technical and management expertise, as well as cost information, by January 29, 2018. This notice is not a request for proposals, and the government will use the submitted information solely to decide whether to proceed with a competitive procurement or a sole source award.

General Info

CRO sought for data management and scientific writing for Leishmaniasis study in Peru.

Agency

Department Of Defense → Naval Medical Logistics Command

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Services to be performed at the contractor's facility in support of Naval Medical Research Unit Six (NAMRU-6), Parasitology De, Bellavista - Callao, MD, PER

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

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Timeline

PhaseClosed

PostedJan 22

Sources Sought

Response DeadlineJan 29

Deadline has passed

Submission Closed

01/29/2018, 02:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Defense → Naval Medical Logistics Command

Contacts2 people available

OfficeFORT DETRICK, MD, 21702-9203, USA

Organization / AgencyDepartment Of Defense → Naval Medical Logistics Command

Office AddressFORT DETRICK, MD, 21702-9203, USA

Contacts

Cheryl Vendemia

contact@example.gov

+1 (555) 000-0000

Thomas L. HoodContracting Officer

contact@example.gov

+1 (555) 000-0000

Full 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 DetectTM 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 DetectTM 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 DetectTM 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 DetectTM 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: contact@example.gov AND contact@example.gov.