SOURCES SOUGHT
A -- Clinical Trial of Topical Thalidomide for Aphthous Stomatitis for Patients with HIV/AIDS
- Notice Date
- 9/4/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Dental and Craniofacial, Bldg 45 center Drive, Room 4AN24E, Bethesda, MD, 20892-5632
- ZIP Code
- 20892-5632
- Solicitation Number
- NIDCR-DR-04-15
- Response Due
- 9/22/2003
- Archive Date
- 10/7/2003
- Point of Contact
- Marion Blevins, NIDCR Contract Office, Phone 301-594-0652, Fax 301-480-8308,
- E-Mail Address
-
marion.blevins@nih.gov
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) serves as a service center to the National Institute of Dental and Craniofacial Research (NIDCR) for research and development contracts. The NIDCR is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as the Coordinating Center for the project entitled: Clinical Trial of Topical Thalidomide for Aphthous in Patients with HIV/AIDS. The applicable NAICS code is 541710 and the size is 500 employees. The purpose of the study is to assess the efficacy and safety of a novel topical thalidomide formulation for healing of aphthous ulcers associated with HIV/AIDS in a Phase II/III clinical trial of 160 subjects. The predicted outcome is that a topical route of administration for thalidomide will result in lesion healing and diminution of pain without the adverse effects inherent in a systemic dose. The Coordinating Center shall be capable of conducting all aspects of a multi-center clinical trial for the treatment of aphthous stomatitis in patients with HIV/AIDS using a topical formulation of thalidomide. The Coordinating Center will have overall responsibility for the operation of the clinical trial and will be responsible for performing the following tasks: 1) Identify up to 10 clinical sites capable of recruiting study subjects 18 years of age or older with HIV infection or AIDS who are experiencing painful oral lesions. Clinical sites identified must be capable of recruiting approximately 10 - 12 patients per year for up to two years, with each subject evaluated weekly and followed up to four weeks beyond study entry. 2) Select and enter into subcontracts with clinical sites by the end of the 3rd contract month and complete site selection by the end of 6th contract month. 3) Using the existing NIDCR protocol, which has been approved by the FDA, and in collaboration with the Government Project Officer, develop, disseminate and revise, as needed, Standard Operating Procedures. 4) Randomize patients and coordinate with the NIH pharmacy, drug dissemination to the clinical sites and maintain appropriate control records. Note: The government (NIH) holds the IND for the test article (drug) and will supply the drug for the study. 5) Assist clinical sites in obtaining and maintaining IRB approval and track protocol violations. 6) Establish a data management plan and possess a computer data storage system that will receive, inventory, and store all information. 7) Perform data analyses of all study data. 8) Comply with DHHS Automated Information Systems Security Program (AISSP) Handbook found at this location: http://irm.cit.nih.gov/policy/aissp.html. Small business firms having demonstrated experience in performing tasks 1-8 above are invited to submit capability statements (original and three copies). Capability statements must provide evidence of experience in performing the tasks described above and demonstrate the following: 1) Qualifications and availability of personnel with experience pertinent to the management and operation of a multi-center clinical trial in HIV/AIDS and/or oral research; 2) Experience in the analysis and interpretation of medical data for the purpose of ensuring patient safety and privacy. 3) Knowledge of regulatory requirements such as HIPAA, GCP, FDA (specifically IND), and human subject protections, including practices of quality control and quality assurance, data and safety monitoring procedures, and IRB policies and procedures. 4) Adequacy of the organizational and administrative structure to participate in a multi-center clinical trial in HIV/AIDS and/or oral research, both in the collection of data from multiple clinical sites as well as experience in monitoring the quality and timeliness of data. 5) Facilities and resources necessary for the performance of the requirements listed above. 6) The firm?s status as a small business under NAICS code 541710. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. This is NOT a Request for Proposals (RFP), and responses should not include budgetary information. The RFP release date is pending. The government intends to negotiate one contract for a period of four years with an approximate award date of August 31, 2004. Firms responding to this market survey should provide information pertinent to the requirements mentioned above (original and three copies) within (15) calendar days from the date of this announcement to the address shown above. Original Point of Contract Kristiane E. Cooper, Contracting Officer, Phone (301) 402-6462, Fax (301 480-3432, E-mail kc116y@nih.gov or Patricia Davis, Chief, BDR Contract Section, Phone (301) 435-0355, Fax (301) 480-3432, E-mail pd15j@nih.gov
- Record
- SN00425049-W 20030906/030904213140 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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