PRESOLICITATION NOTICE
A -- Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT)
- Notice Date
- 1/3/2002
- Notice Type
- Presolicitation 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
- NIH-NIAID-DAIT-02-23
- Response Due
- 3/18/2002
- Archive Date
- 4/2/2002
- Point of Contact
- Scott Drega, Contract Specialist, Phone 301-496-6424, Fax 301-480-5253, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-402-0972,
- E-Mail Address
-
sdrega@niaid.nih.gov, bs92y@nih.gov
- Description
- To address the present needs of the Government, the Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, is requesting proposals to establish and manage a Statistical and Clinical Coordinating Center to provide support for the Autoimmunity Centers of Excellence and the Autoimmune Diseases Transplantation Consortium, hereinafter referred to as the ACEs and the Consortium. These programs design and conduct clinical trials to evaluate the safety, toxicity and efficacy of 1) immunomodulatory and tolerogenic approaches to the treatment and prevention of autoimmune diseases and 2) stem cell transplantation for the treatment of multiple autoimmune diseases, respectively. Both programs also support the design and conduct of studies of the underlying mechanisms of these therapeutic approaches as an integral part of the clinical trials undertaken. The purpose of this seven (7)-year contract is to: (1) provide statistical leadership and clinical trial design expertise for the development, implementation and analysis of clinical trials and studies of underlying mechanisms; (2) establish and administer a reliable, efficient and responsive system for the collection, storage, management, quality assurance and reporting of study data, including systems of patient registration and randomization for clinical trials; (3) conduct clinical site monitoring and training in protocol implementation, as well as data collection, management, quality control and reporting requirements; (4) provide support for regulatory and technical functions and requirements associated with Investigational New Drug (IND) Applications and Investigational Device Exemption applications (IDEs), including adverse event reporting; (5) prepare interim and final analyses of study data, including reports and analyses for review by an independent NIAID Data and Safety Monitoring Board; (6) coordinate and provide support of technical and administrative activities of the ACE Steering Committee, the Consortium Operations/Study Teams, and NIAID Data and Safety Monitoring Boards; and (7) provide for the distribution of study products if needed. This proposed contract will be competed on a full and open basis. RFP NIH-NIAID-DAIT-02-23 will be available electronically on or about January 4, 2002, and may be accessed through the NIAID Contract Management Branch (CMB) Homepage by following electronic address and instructions: NIAID-CMB Homepage (via the World Wide Web): Access by: http://www.niaid.nih.gov/contract and select the "RFPs" link. All responsible businesses may submit a proposal, which will be considered by the Government. This advertisement does not commit the Government to award a contract. It is anticipated that one cost-reimbursement, completion type contract will be awarded for a period of seven (7) years, beginning on/about September 30, 2002. NO COLLECT CALLS WILL BE ACCEPTED. NO FACSIMILIE PROPOSALS WILL BE ACCEPTED.
- Record
- SN20020105/00010991-020104090135 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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