National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- PPRU NETWORK COORDINATING CENTER SOL RFP-NICHD-CRMC-98-05 DUE 031698 POC Mya N. Hlaing, Contracting Officer, (301)496-4611 WEB: National Institutes of Health, http://www.nih.gov. E-MAIL: National Institutes of Health, mh89m@nih.gov. Small Business Set-a-side The National Institute of Child Health and Human Development is planning to award a contract for coordinating a clinical trial of pediatric pharmacolohy research units (PPRU). Seven sites at children's hospital were selected to carry out the overall objectives of facilitating and promoting the pediatric labeling of new drugs or drug already on the market. Labeling of drugs require close interaction between trial sites, the pharmaceutucal company sponsor and the Food and Drug Administration. To accomplish its mission the Network must closely work with the pharmaceutical industry. The PPRU Network conducts two types of studies: 1) Studies originating from pharmaceutical companies and 2) Investigator-initiated studies without a pharmaceutical company sponsorship. The data coordinating center must be capable of: 1) developing and maintaining information information system for tracking the acquisition, start-up, progress, completion, reports, summaries and labeling status of all drugs involved in Network protocols; 2) developing quarterly, annual, and customized reports; 3) preparing and maintaining of operating documents, policies and procedures; 4) Contract Research Organizations (CROs); 5) archiving of data, developing and maintaining of clinical management system, developing of standardized Case Report Forms (CRFs); 6) preparation of IND applications and submission of required FDA reports; 7) developing and maintaining of computerized system for electronic submission of data. Small Businesses that believe they can perform these functions may request a copy of the Request for Proposal. The Request for Proposal NICHD-CRMC-98-05 will be available on or about February 10, 1998. The closing date for the RFP is March 16, 1998. The request for RFP should be sent to: Mrs. Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD, 6100 Executive Building, Suite 7A-07-MSC 7510, Bethesda, Maryland 20892-7510. (0030)

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