National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Natcher Building, Room 5AS-13A, 45 Center Drive, MSC 6500, Bethesda, Maryland 20892-6500

A -- DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS POC Erin Lange, 01-594-2543 The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to negotiate on a sole source basis with Kunitz and Associates, Inc. (KAI), 6001 Montrose Road, Suite 920, Rockville, MD for an additional 400 hours of biostatistical support per year during the period August 1, 1999 through July 31, 2001. The current contract with KAI is entitled Data Integrity Assessments for NIAMS Clinical Trials and is for the establishment and implementation of a system to assist NIAMS grant awardees and scientists in establishing, following, and monitoring standards to preserve data quality and integrity in Institute supported clinical trials. The new work includes biostatistical support for the NIAMS Extramural Programs to carry out research portfolio activities. Activities shall include, but are not limited to, reviewing and providing recommendations regarding proposed clinical research initiatives for statistical design, calculating sample sizes, preparing randomization procedures, reviewing clinical trial methodology, performing interim analyses, computing power calculations, reviewing effect size, performing subanalyses, evaluating outcome measures, and reviewing treatment effect. A determination for the use of other than full and open competition has been made in accordance with 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1. KAI has been determined to be the only responsible source because of the staff's familiarity with the various on-going clinical trials supported by the NIAMS. KAI is in an optimal position to provide this work in a timely and cost-effective manner due to the staff's knowledge of and familiarity with previously assessed on-going clinical trials. Therefore, KAI has the unique capability to perform this work. This is not an announcement of the availability of a Request for Proposal. See Numbered Note 22.***** Posted 06/07/99 (W-SN339968). (0158)

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