National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- INTERNATIONAL CLINICAL TRIALS SUPPORT CONTRACT DUE 012199 POC Dawn Kotzen, Contract Specialist, (301) 496-3699 The National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), is seeking sources that are capable of supporting DMID's growing programs of international clinical trials (Phase I through Phase III) and other clinical and epidemiologic studies. Most (over 20) of the current clinical sites are located in the developing world where the diseases under study are endemic, and most are organized into networks of sites, such as the International Collaborations in Infectious Disease Research. Principle investigators are US- or foreign-based, and their types of support include grants, cooperative agreements and contracts. Key capabilities would include all of those listed below, with heavy emphasis on the consultation and training roles. Offerors should have demonstrated capabilities and field experience to perform the following functions for a wide variety of developing worlds and other sites: 1) provide expertise and training to ensure preparedness of NIAID-sponsored international clinical sites to conduct clinical trials and epidemiologic studies according to current US and international regulatory and ethical requirements, and to develop sites' capacities to perform their own data management, 2) provide statistical and epidemiologic expertise for planning and analyzing such studies, 3) provide direct support in advising sites on how to meet applicable regulatory and ethical requirements and in coordinating collection of the needed documentation's, 4) perform central data management and analysis for selected single- and multi-site studies, and 5) foster collaborative efforts among sites, such as toward common definitions and study approaches. The proposed effort would be a critical component for facilitating a broad array of DMID-sponsored research efforts that are already underway or are envisioned. Interested parties should submit six (6) copies of a capability statement that should, at a minimum, address each of the areas outlined above. This SourcesSought Announcement is a request for information to assist NIAID in the planning of future research. It may or may not result in a solicitation. At this time, no funds are available for these purposes. Interested parties must respond by JANUARY 21, 1999 to the address below. If you have any questions, please contact the below individual at (301) 496-3699 or at dk28a@nih.gov . No collect calls will be accepted. Mrs. Dawn Caracci Contract Specialist Contract Management Branch National Institute of Allergy and Infectious Diseases National Institutes of Health Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, Maryland 20892 *For Express Mail or Overnight Delivery, use Rockville, Maryland 20852 Posted 01/06/99 (W-SN285711). (0006)

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