Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF APRIL 6,1995 PSA#1319

National Heart, Lung, and Blood Institute, BDR Contracts Section, Contracts Operations Branch, Federal Building, Room 610, National Institutes of Health, Bethesda, MD 20892

A -- MEDICAL COORDINATING CENTER FOR CORD BLOOD STEM CELL TRANSPLANTATION STUDY SOL NHLBI-HB-95-07 POC Lynda A. Bindseil, Contracting Officer, (301) 496-3513. The National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to assess the availability and potential technical capability of small business firms as defined by Standard Industrial Classification Code (SIC) 7379, $18.0 million, Computer Related Services, N.E.C. to perform as a Medical Coordinating Center (MCC) for a phase I-II clinical trial (estimated 2-4 umbilical cord blood banks and 6-8 transplant centers) designed to determine if stem and progenitor cells (CBSPC) from umbilical cord blood are a clinically acceptable alternative to those from marrow or peripheral blood for unrelated donor allogeneic transplantation. It is anticipated that four groups of 75 patients each (total 300), will be transplanted for this four- year study. In addition, the initial goal for the number of cord blood units in multiple cord blood banks will be 20,000. The MCC will establish a centralized electronic database registry of banked cord blood units that will include information on each unit that is stored in a participating blood bank. The MCC must have, or must create within 4 months of contract award, an electronic search algorithm to permit checking the database rapidly for the best available HLA matches. The MCC will manage donor searches, facilitate the provision of cord blood units for transplantation, and collect and analyze data from these transplants. The database management capability must be sophisticated and flexible enough to accommodate class I and class II HLA typing (both serological and DNA-based) and changes in interpretation, as the state of science evolves. The search algorithm must be able to detect and describe the degrees of matches within the database and be flexible enough to accommodate modifications of match criteria, as science dictates. The ability to recognize cross-reacting antigens and those with similar molecular structures must be available when needed. As knowledge in the field of tissue antigen typing and matching expands, the search algorithms may need to be modified to improve the definition of suitable donors and the outcome of the transplants. The MCC must also collect data on the outcome of the CBSPC transplants, analyze the recipient data, including survival, disease status, complications and other aspects of the transplant follow-up. Working under the auspices and with the concurrence of the NHLBI, the MCC in conjunction with the participating organizations, will establish standards for the collection, testing, storage, shipping and use of CBSPC for transplantation. Should there be a need to add contractors to accomplish the number and type of transplants performed, the MCC will assist in the gathering of data necessary for the NHLBI to determine how and when the number involved must be expanded. The MCC will have responsibility for the overall coordination, monitoring, and central management of all activities required by the study protocol, manual of operations, data collection, and data analysis. Small business firms having demonstrated research and development capabilities for ongoing design, coordination and analysis of long-term, multicenter studies related to marrow transplantation, or other clinical trials of similar complexity are invited to submit capability statements. Information furnished should establish (1) qualification of medical, scientific, technical, and administrative staff with experience pertinent to the operation of a medical coordinating center for a multicenter phase I-II clinical trial to accomplish the above mentioned activities, (2) the ability to create, within 4 months of contract award, an electronic data-base and search algorithm, (3) the ability to coordinate, monitor, and manage study activities, including those related to data collection, management, and analysis, (4) evidence of administrative and scientific leadership, including biostatistics, in medical coordinating center activities, (5) the availability of facilities, space, and equipment necessary for the conduct of this study, and (6) the firm's status as a small business under SIC code 7379. This is not a Request for Proposal (RFP). The RFP release date is pending. Three copies of the capability statement must be submitted within thirty (30) calendar days including the date of publication of this announcement in the Commerce Business Daily (CBD). (0094)

Loren Data Corp. http://www.ld.com (SYN# 0008 19950405\A-0008.SOL)


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