Food & Waterborne Diseases Intergrated Research Network: Coordinating and Biostatistics Center

General Information Document Type: Special Notice Solicitation Number: JOFOC-HHS-NIH-NIAID(AI)-SS-30051 Posted Date: August 6, 2010 Archive Date: August 20, 2010 Original Response Date: Current Response Date: Classification Code: A --Research & Development Contracting Office Address Department of Health and Human Services National Institutes of Health National Institutes of Allergy and Infectious Diseases Office of Acquisitions 6700 B Rockledge Room 3214, MSC 7612 Bethesda, MD 20892 Description The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services (HHS) provides biostatistical, administrative and coordinating support for enteric research trials that includes data management while collaborating with other organizations and clinical centers. The Emmes Corporation received one of seven contracts awarded in 2003 as part of the NIAID Food & WaterBorne Diseases Integrated Research Network. The purpose of the contract is to facilitate and ease the advancement and successful progression of three ongoing trials, two of which will end within six to twelve months. This acquisition shall provide a short-term continuation of biostatistical, operational and monitoring support for the existing trials to prevent and treat food and waterborne diseases that threaten public health and to facilitate product development. The contractor shall provide computing and Data Management support, Web-based data collection, data management and other related applications in compliance with relevant regulatory guidelines including 21 CFR 11 and HIPAA. The contractor shall employ a compliant audit trail automated query generator to ensure high levels of completeness and quality. The support system and its processes shall be compatible with current Clinical Research Unit (CRU ) system and also compatible with the NIAID and NIAID's contractor utilized in the ongoing clinical projects. The Contractor shall support data collection, evaluation, analysis, reporting, and provide the supporting services of an Application Service Provider (ASP), hosting project applications and providing safekeeping of data collected under the contract The Contractor shall archive and backup, provide data security, and maintain high levels of system availability supported by redundant components and backup power. A mirrored co-location facility shall be provided to minimize the disruptive effect of system outages. This Contractor shall continue providing support to the CRU clinical projects conducted at the Center of Vaccine Disease (CVD) located at the University of Maryland, Baltimore (UMB). This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. This is not a request for competitive proposals. However, interested parties who believe that they are capable of fulfilling this requirement may identify their interest by providing clear and comprehensive information supporting their claim. Please include contact person(s) and phone number(s), and identify the type of business, e.g. educational institution, small business, large for profit, research non-profit, etc. A determination by the Government not to compete this requirement is solely within its discretion. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If this portion of the EMMES requirement were awarded to another contactor at this time, the consequence would result in disruption of clinical trials and inconsistency of normal operations of a clinical trial. Anticipated Period of Performance - It is anticipated this work will be conducted under a cost reimbursement contract with a period of performance of 2 years.. Point of Contact Gehmelle Johnson, Contract Specialist, Phone 301-496-0612, Fax 301-480-4675, Email gjohnson@niaid.nih.gov - Rich Hartmann, Contracting Officer, Phone 301-496-0612, Fax 301-480-4675, Email: Richard.Hartmann@nih.gov