NOT-AI-02-044: RFP ANNOUNCEMENT: HIV CLINICAL RESEARCH MANAGEMENT SUPPORT

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

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: [email protected]
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