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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 07, 2019 FBO #6495
DOCUMENT

A -- Clinical Trial Consulting Services for Research with the VA Salt Lake City Healthcare System - Attachment

Notice Date

9/5/2019
 

Notice Type

Attachment
 

NAICS

541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Regional Procurement Office (RPO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

36C24E19Q0169
 

Archive Date

9/6/2019
 

Point of Contact

Linda A Buccigrossi - Contractor
 

E-Mail Address

822-3763<br
 

Small Business Set-Aside

N/A
 

Description

INTENT TO SOLE SOURCE The VA Salt Lake City Healthcare System (Research & Development), located at 500 Foothill Drive, Salt Lake City UT intends to negotiate on a sole-source basis with Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA LLC) located at 1050 K Street NW Suite 1000, Washington DC, 20001, pursuant to FAR 6.302-1(only one source) for the procurement of Clinical Research Organization (CRO) services needed to prepare, manage and provide regulatory oversight of an osseointegrated Early Feasibility Study of a new orthopedic device that is being studied at the VA include: FDA Early Feasibility Study of an osseointegrated device for amputees Submission Guidance and Review Early Feasibility Study trial training and site preparations Site management, Regulatory monitoring visits Remote site management Regulatory study training Communication with FDA Communications with the device manufacturer Development of data management plan Electronic clinical report forms guidance and preparation Quality review of study data Annual audit for FDA compliance RedCap system audit Database closeout Institutional Review Board Oversight and managements, FDA reporting FDA notification preparation. MCRA previously performed Early Feasibility Study of an osseointegrated devise consulting and has the knowledge of the preclinical and clinical work performed at the Salt Lake City VA on this technology. This notice of intent is not a request for competitive quotes; however any responsible source who believes it is capable of meeting this requirement may submit a capability statement to the contracting office no later than Monday, September 9th at 10:00 AM ET. Interest/capability statements may be sent to Linda Buccigrossi at linda.buccigrossi@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government. The NAICS code for this procurement is 541714
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/2f8693456b87b4e37041c8e85023b659)
 

Document(s)

Attachment
 

File Name: 36C24E19Q0169 36C24E19Q0169.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=5142340&FileName=36C24E19Q0169-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=5142340&FileName=36C24E19Q0169-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN05431939-W 20190907/190905230907-2f8693456b87b4e37041c8e85023b659 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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