RFP ANNOUNCEMENT: HIV CLINICAL RESEARCH MANAGEMENT SUPPORT - NIH-NIAID-DAIDS- 03-25 Release Date: August 14, 2002 NOTICE: NOT-AI-02-044 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: October 22, 2002 DESCRIPTION The AIDS pandemic has impeded the health, economic development, and political stability of many of the world's poorest and most vulnerable populations. In recognition of this global threat and to prevent the spread of HIV infection and other bio-organisms, the National Institute of Allergy and Infectious Diseases (NIAID) and the Division of AIDS (DAIDS) sponsors the conduct of Phase I-III trials testing vaccines and therapeutics, as well as preventive modalities (e.g. microbicides). DAIDS has extensive clinical trial networks and development contracts for the scientific development and testing of such products. These include the Adult AIDS Clinical Trials Group (AACTG), the Pediatric AIDS Clinical Trials Group (PACTG), the HIV Prevention Trials Network (HPTN) and the HIV Vaccine Trials Network (HVTN). In addition to these networks, DAIDS has fostered the development of vaccines and the testing of these products through industry partnerships, investigator initiated projects (R01s), and through inter-agency agreements with the Centers for Disease Control, and Department of Defense. With a maturing pipeline of clinical trials and an increased focus on clinical trial conduct in international settings, DAIDS will need to augment its current clinical trials management capacity, especially in international settings. Additionally, DAIDS is the Investigational New Drug (IND) sponsor for many of its current trials. Therefore, with this Request for Proposal (RFP), DAIDS is seeking a contractor to provide comprehensive clinical trial management for a variety of clinical research efforts. Specific tasks performed within this contract will vary and will be trial-specific. For example, the contractor may provide quality assurance monitoring and medical writing for one Phase III trial within an established vaccine network; data management and site management support for an industry- sponsored Phase II trial; and an entire spectrum of clinical trials support services (design, initiation, management) for a third trial, initiated by an investigator (R01). The contractor must have the capacity and capability to work with DAIDS-specified grantees and contractors, and must possess the ability to establish necessary linkages (administrative, logistical, operational, Information Technology (IT), etc) as required for sound clinical trial management. It is anticipated that one (1) contract will be awarded for a period of five (5) years, beginning approximately June 2, 2003. RFP-NIH-NIAID-DAIDS-03-25 will be available electronically on or about July 22, 2002 and may be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and will be on Fed Biz Opps at http://www.fedbizopps.gov. Responses to this RFP will be due on October 22, 2002 by 4:00 pm. Any responsible offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Barbara A. Shadrick, Senior Contracting Officer, Phone: 301-496-7288; FAX: 301-480-5253; E-Mail: bs92y@nih.gov
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