SOLICITATION NOTICE
R -- TB Trials Consortium Study 27
- Notice Date
- 11/22/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2003-N-00771
- Archive Date
- 1/31/2003
- Point of Contact
- Cynthia Collins, Contract Specialist, Phone 770-488-2757, Fax 770-488-2688, - Charlotte Flitcraft, Contract Specialist, Phone (770)488-2632, Fax (770)488-2847,
- E-Mail Address
-
coc9@cdc.gov, cflitcraft@cdc.gov
- Description
- The Centers for Disease Control and Prevention intends to negotiate on a sole source basis with Case Western Reserve University School of Medicine a requirement for a three-year contract to collaborate with CDC's TB Trials Consortium in a phase 2 trial of moxifloxacin versus ethambutol in the 4-drug intensive phase of treatment of tuberculosis. Through its field collaboration with Makerere University in Kampala, Uganda, Case Western can assure access to large numbers of patients with active TB disease who can be enrolled within 7 days of the start of TB therapy, treated with FDA-approved companion medications, and monitored by an experienced clinical staff able to comply with FDA requirements for Good Clinical Practices. The site must also have ready access to a fully qualified mycobacteriology laboratory, and must be experienced in data management for large scale clinical trials, and must have an available ethics committee meeting all Office for Human Research Protections (OHRP) requirements. The site must be capable of enrolling 150 patients over the course of two years, and following patients during the full six months of TB treatment. Moreover, because costly supplies of study drugs and matching placebo will expire in early 2005, the site must be able promptly to begin enrollment immediately following the expected award date of April 1, 2003. Case Western is the only known contractor with the unique capacity in the area of TB clinical trials AND who possesses the current capacity to satisfy the stringent time requirements for this procurement. Interested persons may identify their interest and capability to respond to the requirement by notifying Cynthia R. Collins by email at coc9@cdc.gov or by facsimile at 770-488-2688. Note 22.
- Place of Performance
- Address: Kampala, Uganda
- Record
- SN00208722-W 20021123/021122062916 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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