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A -- Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

Solicitation Number: RFP-NIH-NIAID-DMID-08-04
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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RFP-NIH-NIAID-DMID-08-04
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Solicitation
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Added: December 7, 2006 Modified: December 22, 2006Track Changes
NOTICE HAS BEEN REVISED TO CHANGE ANTICIPATED POSTING DATE OF RFP FROM DECEMBER 21, 2006 TO JANUARY 2, 2007.
The Office of Clinical Research Affairs (OCRA) of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), intends to recompete a requirement for capabilities and facilities to establish and manage a Statistical and Data Coordinating Center (SDCC) to support NIAID sponsored clinical research programs in infectious diseases. This is a 100% SMALL BUSINESS SET-ASIDE, NAICS 541710 with a size standard of 500 employees. It is anticipated that a single cost reimbursement completion type contract will be awarded for a 7-year period with performance beginning on or about March 3, 2008, with an anticipated total effort of approximately 40.75 FTEs.

The NIAID, DMID supports extramural research to understand and ultimately prevent and/or treat diseases caused by virtually all infectious agents other than HIV that threaten millions of lives every year. This includes basic and applied research to develop and evaluate therapeutics, vaccines and diagnostics which are funded through a variety of research grants and contracts. DMID is also responsible for advancing clinical research and conducting clinical trials to evaluate the safety and efficacy of vaccines and therapeutic agents against potential bioterrorist pathogens and new and re-emerging infectious diseases of public health importance, such as avian influenza and SARS.

The primary goal of this seven-year effort is to facilitate the evaluation of new vaccines, other prophylactic strategies, and therapeutic agents for infectious diseases of priority to the Division. Support will be provided for single- and multi-center Phase 1, 2, 3 and 4 clinical trials of vaccines, other biologics, therapeutic agents aimed at bacterial, viral and parasitic diseases that occur in people of all ages at DMID-sponsored Vaccine and Treatment Evaluation Units (VTEUs) and other clinical research centers. The contractor's primary goal will be to coordinate clinical trials with respect to elements of study planning and logistics, training and communications, data collection, management and analysis and related support activities. This will typically involve a multi-center effort and a collaborative relationship with clinical investigators, other supporting contractors and DMID staff.

The support services to be provided by the contractor under this contract include the following: 1) computerized systems for the collection, management, storage, security, reporting and quality control of study data including systems to accommodate on-line subject enrollment and randomization; 2) statistical expertise in study design and analysis of trials; 3) assistance with preparation of study-related materials such as Manuals of Operations, case report forms and/or source documents and tracking logs; 4) development and maintenance of protocol web sites to share information and study materials with study sites and to provide DMID with real-time study information, such as overall and site-specific accrual, demographics, adverse events, queries, and deviations; 5) development and maintenance of an electronic inventory system to identify and track clinical study specimens; 6) providing training to clinical site staff to access the data system, perform remote data entry and enter clinical specimens into the electronic inventory system; 7) assessing capabilities and providing assistance to sites that intend to perform their own data collection, management, security and quality control; and 8) serving as a repository to store data from completed studies.

The Request for Proposal document will be available electronically on or about January 2, 2007, and may be accessed through the FedBizOpps . No collect calls will be accepted. No facsimile or e-mail transmissions will be accepted. See Government-wide Numbered Note 26.
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Solicitation 1

Type:
Solicitation
Posted Date:
December 29, 2006
Description: RFP-NIH-NIAID-DMID-08-04

Amendment 1

Type:
Mod/Amendment
Posted Date:
February 6, 2007
Description: RFP-NIH-NIAID-DMID-08-04 Amendment 1

Amendment 2

Type:
Mod/Amendment
Posted Date:
April 4, 2007
Description: Amendment 2 Q & A 1st Posting
Description: Amendment 3
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Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
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Deborah Baca, Contract Specialist, Phone 301-443-4490, Fax null, Email dbaca@mail.nih.gov