A -- STATISTICAL AND CLINICAL COORDINATING CENTER -- CLINICAL TRIALS OF STEM CELL TRANSPLANTATION FOR TREATMENT OF AUTOIMMUNE DISEASES (SACCC-SCTTAD)

Notice Date

December 13, 2000

Contracting Office

National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

ZIP Code

20892-7612

Solicitation Number

RFP NIH-NIAID-DAIT-01-20

Response Due

March 15, 2001

Point of Contact

Scott Drega, Contract Specialist, telephone: 301-496-6424; fax: 301-402-0972

E-Mail Address

Scott Drega (sdrega@niaid.nih.gov)

Description

THIS PROCUREMENT IS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 541710, SIZE STANDARD 500 EMPLOYEES. (SEE NUMBERED Note 1) The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement for a Contractor having the capabilities and facilities to establish and manage a Statistical and Clinical Coordinating Center (SACCC) to support the NIAID Clinical Trials of Stem Cell for Treatment of Autoimmune Diseases established in FY 2000. The purpose of this program is to support prospective, multi-site phase II/III randomized cooperative clinical trials of stem cell transplantation for the treatment of autoimmune diseases and associated mechanistic studies. Phase 1 studies may also be performed. The program will perform: a) Clinical trials of the safety and efficacy of hematopoeitic stem cell transplantation compared to standard therapeutic approaches to treat severe progressive autoimmune disease; and b) Adjunct studies of the underlying mechanisms of action of the therapeutic approach being evaluated, including changes in immune response and function, and development of surrogate markers of disease activity. Specifically, this requirement will provide the statistical, clinical, regulatory, technical and administrative expertise necessary to support clinical trials and mechanistic studies of stem cell transplantation to treat various autoimmune diseases, including: (1) statistical leadership in the design, implementation and analysis of clinical trials and studies of underlying mechanisms; (2) establishment and administration of systems for the collection, storage, management, quality assurance and reporting of study data; (3) clinical site monitoring and training; (4) regulatory and technical functions and requirements associated with Investigational New Drug applications (INDs) and Investigational Device Exemption (IDE) applications; (5) preparation and final analyses of study data (6) coordination and support of technical and administrative activities of the SCTTAD Operations Committee, SCTTAD Study Committees, and an independent Data and Safety Monitoring Board (DSMB); and (7) provide for the receipt, storage and distribution of study devices, drugs or biologics being tested. The procurement will be conducted on a 100% small business set aside basis and in accordance with FAR Part 15. Request For Proposal (RFP) NIH-NIAID-DAIT-01-20 will be available ELECTRONICALLY on or after December 28, 2000, and may be accessed through the NIAID Contract Management Branch (CMB) Homepage (via the World Wide Web): access by: http://www.niaid.nih.gov/contract and select the "RFPs" link. All qualifying Small 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 (1) cost-reimbursement, completion type contract will be awarded for a period of seven (7) years, beginning on/about August 15, 2001. Collect calls regarding the RFP will not be accepted.

Web Link

NIAID Home Page (http://www.niaid.nih.gov/contract)

Record

Loren Data Corp. 20001215/ASOL007.HTM (W-348 SN508897)