Notice Number: NOT-AI-07-017
Release Date: December 15, 2006
Receipt Date: April 23, 2007
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
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.
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.
It is anticipated that up to one cost reimbursement completion type contract will be awarded for a period of seven years, beginning approximately March 3, 2008, with an anticipated total effort of approximately 40.75 FTEs. This RFP will be available electronically on or about December 21, 2006, and may be accessed at http://www.fedbizopps.gov/. Only electronic copies of the RFP will be available. All information required for the submission of an offer will be contained in the RFP. Responses to this RFP will be due approximately April 23, 2007.
This is a 100% SMALL BUSINESS SET-ASIDE, NAICS 541710 with a size standard of 500 employees. Any responsible offeror who meets this size standard may submit a proposal that will be considered by the Government, however, this notice does not commit the Government to the award of a contract. No collect calls will be accepted. No facsimile or e-mail transmissions will be accepted.
Inquiries regarding this notice may be directed to:
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612 (Express mail: Use Zip Code 20817-7612)
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NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)