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Clinical Studies Network (CSN) Statistical and Data Coordinating Center (SDCC)   2

ID: 75A50119R00027 • Type: Solicitation • Match:  90%
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Description

AMENDMENT 1: Offerors should review all pages of the Amendment and provide acknowledgement of receipt of the Amendment as required on the SF 30 part 11. The receipt of proposals due date is extended to Monday October 21, 2019 at 12 pm Eastern Time.
Background
The solicitation is issued by BARDA for the Clinical Studies Network (CSN) Statistical and Data Coordinating Center (SDCC). The goal is to establish a robust infrastructure for managing clinical study records and coordinating statistical data.

Work Details
The SDCC will manage electronic Trial Master Files (eTMFs) for clinical studies funded under the current MCM CSN contract. Tasks include receiving eTMFs for four CSN-funded studies within the first 6 months following award, providing both remote and on-site access to TMF archives primarily for regulatory compliance/audit purposes, and supporting eCTD submission with reasonable assumptions based on similar studies.

The SDCC should also prepare various plans such as Project Management Plan, Security Plan, and Continuity of Service Plan, which are lengthy but necessary components of the proposal.

Period of Performance
The IDIQ base contract will start on the date of award. Routine RTOR0001 will start 6 months following IDIQ award, and Response RTOR0002 will start 12 months following IDIQ award.
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Overview

Agency
HHS Immediate Office of the Secretary (IOS) [HHS]
Response Deadline
Oct. 21, 2019, 1:00 p.m. EDT Past Due
Posted
Sept. 25, 2019, 11:59 a.m. EDT
Set Aside
None
NAICS
541714 - Research and Development in Biotechnology (except Nanobiotechnology)
PSC
A - Research And Development
Place of Performance
Not Provided
Source
Open
Current SBA Size Standard
1000 Employees
Est. Level of Competition
Average
On 9/25/19 HHS Immediate Office of the Secretary issued Solicitation 75A50119R00027 for Clinical Studies Network (CSN) Statistical and Data Coordinating Center (SDCC) due 10/21/19. The opportunity was issued full & open with NAICS 541714 and PSC A.
Primary Contact
Title
Contracting Officer
Name
Jeffrey E. Brown   Profile
Email
jeffrey.brown@hhs.gov
Phone
(202) 730-8662

Secondary Contact

Title
Contracting Officer
Name
Enrique Manan   Profile
Email
enrique.manan@hhs.gov
Phone
None

Documents

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > IMMED OFFICE OF THE SECRETARY OF HEALTH AND HUMAN SERVICES > Acquisitions Management, Contracts, & Grants (AMCG)
Source Organization Code
b67f10c42dff7fb763de08f7751530e8
Last Updated
Sept. 25, 2019
Last Updated By
PI33_DR_IAE_51681
Archive Date
Sept. 25, 2019