National Institutes of Health, Research Contracts Branch, DCG/OA/OD, 6100 Executive Blvd., MSC 7540, Room 6E01, Bethesda, Maryland 20892- 7540

A -- CLINICAL TRIALS AND STATISTICAL STUDY MONITORING AND COORDINATION SOL NIH-EY-95-07 DUE 061695 POC Karen M. Gamble, Contracting Officer, 301-496-4487. The National Institutes of Health has a requirement for Clinical Trials and Statistical Study Monitoring and Coordination for Ophthalmic Clinical Trials. The contractor shall provide clinical trial design, study design, sample size calculations, and identification of appropriate study endpoints and statistical analyses. Reading center services for the evaluation of photographs and fluorescein angiograms will also be required. Other required services include: development and preparation of protocols, collection of data elements and analysis of study data including standard statistical techniques utilized in the analysis of clinical trials, preparation of reports by protocol, as well as comprehensive reporting of treatment-related toxicity, notification of protocol violations or reported toxicities of investigational drugs, clinic coordinators to assist in the conduct of trials, assistance in the design of a computerized system to organize clinical data collected during ocular examinations, the capability of reproducibly analyzing external and internal ophthalmic photographs and fluorescein angiograms of study patients, and assistance in the development and preparation of publicity materials for clinical trials to improve patient recruitment. The requirement also includes natural history and outcomes research studies involving as many as 10 clinics. The contractor shall support these studies by providing assistance in the retrieval, formatting and analysis of information for the interpretation and evaluation of data. Integrity of research must be protected including assuring patient safety through a data and safety monitoring committee. Personnel must be well qualified in ophthalmic epidemiology and clinical trials. Request for Proposal (RFP) NIH-EY-95-07 will be available 15 days from the date of this publication. Written requests should be submitted to the above address or may be faxed to (301) 402-0178. The Standard Industrial Classification (SIC) Code is 7379. This is a small business set-aside. See Numbered Note(s): 1. (0117)

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