SPECIAL NOTICE
A -- Clinical Site Monitoring Project
- Notice Date
- 12/13/2004
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Archive Date
- 2/11/2005
- Point of Contact
- David Lisle, Contract Specialist, Phone 301-496-0612, Fax 301-402-0972, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
- E-Mail Address
-
DLisle@niaid.nih.gov, bs92y@nih.gov
- Description
- The Division of AIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to extend the current contract N01-AI-05405 with Pharmaceutical Product Development (PPD) for 18 months until December 31, 2006 under Authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(b)(1)(i), Unique Capabilities. The NIAID has undertaken a restructuring of the DAIDS funded networks and since the current monitoring contract scope of work is directly related to the structure of these networks and the potential for change is significant, an extension of the contract is required. The present monitoring strategy was developed during the 1990’s when NIAID expended very few clinical trial resources internationally and when most of our network research dollars were devoted to therapeutic interventions. In 2000, DAIDS funded both a Vaccine Trials network and a Prevention Trials network that expanded significantly into resource poor settings. The scope of work of the 2000 monitoring contract included these new networks but used the “therapeutic” model for monitoring which included quarterly visits for main units and twice yearly visits for subunits. This approach is less than perfect for Prevention sites that may participate in Maternal to Child transmission studies, Behavioral Intervention studies, and Microbicide studies all with different staff and in different locations within the same grant institution. The one-size fits all approach is no longer optimal. As the sponsor of federally funded clinical trials research, DAIDS has an on-going regulatory responsibility for oversight of some 200 studies conducted at over 900 sites in 43 countries, and PPD has assumed a significant part of this responsibility through this contract. PPD currently provides domestic and international on-site monitoring and training services for the Adult AIDS Clinical Trials Group (AACTG), Pediatric AIDS Clinical Trials Group (PACTG), the Acute Infection Early Disease Research Program (AIEDRP), the Community Programs for Clinical Research on AIDS (CPCRA), the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), and two large non-network trials ESPRIT and SMART. In responding to the scientific priorities of the evolving HIV/AIDS epidemic, larger and more complex studies have been implemented in the last several years that have necessitated shifts in how often and what we monitor. The negotiated 18 month extension of this contract will allow NIAID to link the re-structuring of the HIV/AIDS clinical trials networks to the re-evaluation of our monitoring strategy while providing continuous oversight of our on-going studies. PPD is uniquely qualified to continue to fulfill these requirements by virtue of their performance under the current contract. If this portion of the PPD requirement were awarded to another contractor at this time, the consequences would mean an interruption and/or inconsistency in the normal monitoring operations of DAIDS. Therefore, no other service will satisfy Agency requirements. If there are responsible sources who feel that they are able to perform the requirement, they must respond by submitting their interest and a capability statement demonstrating their ability to assume the work without unnecessary delay and duplication of costs and effort. See Government-Wide Numbered Notes 22 and 26. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (13-DEC-2004); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIAID/JOFOC-SYNOPSIS-N01-AI-05405/listing.html)
- Record
- SN00720727-F 20041215/041213212036 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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