R -- Evaluating and Validating the Structure of a Clinical Trial Results Database

Evaluating and Validating the Structure of a Clinical Trial Results Database It is the intent of National Library of Medicine (NLM) to procure on a sole source basis with the University of Ottawa, Canada, for professional services with the expertise in systematic reviews, evidence-based medicine, and randomized clinical trial reporting methodology. The period of performance will be over a 12 month period to assist in the development and validation of a database to organize and to archive the key results of clinical trials for a publicly available database. The University of Ottawa is uniquely qualified for this service in that it developed the Consolidated Standards of Reporting Trials (CONSORT) statements, revisions, and extensions which provide reporting guideline to improve reporting of clinical trial results. The University of Ottawa is also a leading force behind the development on ongoing work of the guidance for the reporting of systematic reviews. The University of Ottawa CONSORT Group Executive and Coordinators will assist in developing and assessing forms for data collection and will evaluate the clinical trial results display for completeness, appropriateness, and utility for general scientific users, medical administrators, and groups interested in systematically reviewing the results of clinical trials. The work to be performed is primarily an intellectual process, requiring advanced knowledge of the reporting of clinical trial results, including critical data elements and design and analysis features of reporting. The contractor will work off-site using her/his own hardware/software and make periodic visits to NLM for group discussions, as necessary. The proposed acquisition will be procured under FAR Part 12 and FAR Part 6.301-1. This is not a Request for Quotations (RFQ), nor is an RFQ available, however, all responsible sources may submit a proposal which will be considered by the NLM. Firms interested in responding to this notice must be able to provide service as specified above. Responses must be in writing and must be received in this office within ten (10) calendar days from publication date of this notice, and must include pricing information and meet the criteria requirement. Inquiries regarding this procurement may be made to the National Library of Medicine, Office of Acquisition Management, 8600 Rockville Pike, Building 38A, Room B1N17, Bethesda, Maryland 20894 Attention: Joan Coulter, Business Opportunity Specialist, on (+1 (555) 000-0000) with a CC to Karen Riggs, Contracting Officer at the same location as Joan Coulter will be unavailable for questions during this posting period. Fax requests WILL NOT BE ACCEPTED.