SOLICITATION NOTICE
A -- HIV Clinical Research Management Support
- Notice Date
- 7/18/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700-B Rockledge Drive, MSC 7612 Room 2230, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DAIDS-03-25
- Response Due
- 10/22/2002
- Point of Contact
- Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-402-0972,
- E-Mail Address
-
bs92y@nih.gov
- Description
- The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking organizations with clinical and technical expertise and facilities to advance the Vaccine Clinical Research Branch (VCRB), Division of AIDS (DAIDS) clinical research mission through the provision of flexible research management support at multiple levels to facilitate a complex and rapidly evolving global research agenda. DAIDS is seeking a contractor to provide comprehensive clinical trial management for a variety of Phase I, II and III HIV clinical research efforts. This is a new effort; there is no incumbent. NAICS CODE 541710, WITH A SIZE STANDARD OF 500 EMPLOYEES. This critical contract will exist within a complex research environment and a consortium of multiple clinical trial groups which are primarily international in scope and conducted in developing countries. Specific tasks performed within this contract will vary and will be trial-specific. The contractor must have the capacity and capability to work with DAIDS-specified grantees and contractors and must possess the ability and relevant scientific expertise to establish necessary linkages (administrative, logistical, operational, information technology, etc.) as required for sound clinical trial management. This new contract will be awarded as a cost-reimbursement contract with the emphasis being on the contractor's ability to provide rapid response to requests for support to the Division of AIDS. Major support activities will include clinical research management; logistical support (to include a call center and 1-800 center); training; infrastructure support; site assessment; site management; site evaluations; planning, initiation and conduct of DAIDS Phase I, II and III trials; document generation; regulatory support; monitoring and quality assurance; data collection and management; biostatistics; product/agent distribution; project management; safety monitoring; laboratory assistance to on-site labs; shipping and state-of-the art information technology support for large scale, international clinical trials. Offerors will be evaluated on: staff and expertise in the conduct of large trials in resource-constrained areas such as Asia, Africa, Eastern Europe and India; experience in similar projects (clinical trials) with special emphasis on the ability to anticipate special conditions likely encountered among resource-constrained sites in developing countries; experience in working with the political and diplomatic demands of clinical trials management in international settings; maintaining a pool of experienced monitors ready to travel within 10 days notice; ability to provide comprehensive clinical research management services of Phase I, II and III HIV clinical trials with emphasis in international settings and infectious diseases/vaccines (including all aspects of clinical trial conduct); ability to provide site management, assessment, evaluation and management services including training and operational/remedial site visits/actions; provision of IT support and infrastructure development for IT capacity in resource-constrained countries; an established enterprise system for linking of databases; experience in comprehensive conduct (planning, initiation and conduct) of clinical trials in both domestic and international settings with the emphasis on international; experience in managing large complex clinical research programs; proximity of management core of key personnel to the Washington, D.C. area to be available within a two-hour timeframe for face-to-face meeting with DAIDS staff; and willingness to partner with Contract Research Organizations (CROs), Site Management Organizations (SMOs), Federal entities, pharmaceutical companies, and Non-Governmental Organizations (NGOs). It is anticipated that the period of performance for this contract will be a total of five years with an estimated level-of-effort of 216,320 labor hours per year. This RFP will be available electronically on the CMB Homepage on or about July 22, 2002, and may also be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps at www.fedbizopps.gov. Any responsible offeror may submit a proposal that will be considered by the Government. This announcement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Record
- SN00120178-W 20020720/020718213850 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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