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 NICHD-CRMC-98-05 DUE 010598 POC Ms. Mya N. Hlaing, Contracting Officer, (301)496-4611 WEB: National Institutes of Health, http://www.nih.gov. E-MAIL: National Institutes of Health, hlaingm@hd01.nichd.nih.gov. Sources Sought Announcement: The National Institute of Child Health and Human Development (NICHD), NIH is seeking sources which are small businesses capable of coordinating a clinical trial of pediatric pharmacology 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 drugs already on the market. Labeling of drugs require close interaction between trial sites, the pharmaceutical company sponsor and the Food and Drug Administration. To accomplish its mission the Network must work closely 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 system for tracking the acquisition, start-up, progress, completion, reports, summaries andlabeling 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 (CRO's); 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 that they have the capabilities to perform the functions listed above should submit a short statement which specifically addresses each of the areas to: Ms. Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD, 6100 Executive Building, Suite 7A-07-MSC 7510, Bethesda, Maryland 20892-7510. (0343)

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