SOURCES SOUGHT
A -- Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases
- Notice Date
- 8/21/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- SS-RFP-NIH-NIAID-DMID-08-04
- Response Due
- 9/5/2006
- Archive Date
- 9/8/2006
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE, 100% SMALL BUSINESS SET-ASIDE, OR UNDER FULL AND OPEN COMPETION . ALL ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), is seeking contractors capable of providing comprehensive statistical support, data management and analysis activities for DMID-sponsored clinical work. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics which are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine and therapeutic candidates in clinical trials and clinical studies is an essential element of DMID efforts. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase I, II, III and IV clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, including: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines and therapeutics against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm), and to meet critical public health needs and opportunities for emerging and re-emerging infectious diseases, such as Severe Acute Respiratory Syndrome (SARS) and avian influenza. The Contractor must be capable of establishing and managing a Statistical and Data Coordinating Center (SDCC) to support DMID?s extramural clinical research programs through the provision of: statistical design and analysis expertise; computerized systems for the collection, storage, management, reporting and quality control of study data; assistance in the preparation of study-related materials and instructions; a system for the tracking of clinical specimens; training of clinical site staff and assessment of clinical site capabilities for data collection and management; and a data repository for completed DMID-sponsored clinical studies. The contractor must also be capable of facilitating the evaluation of new vaccines and other prophylactic and therapeutic agents of priority to the DMID by providing data coordination and related research support functions for Division-sponsored multi-center Phase I, II, III and IV clinical trials. The multi-faceted goal of this effort would be to provide sound study design, facilitate study implementation in accordance with clinical and regulatory guidelines, provide for secure and efficient data management, and to perform data analysis. Specifically, the Contractor?s must be capable of serving as a coordinating center for DMID clinical and epidemiologic studies with respect to elements of study design, planning and logistics, training and communications, data collection, management and analysis and related support activities. This typically would involve a multi-center effort and a collaborative relationship among clinical investigators, other supporting Contractors and DMID staff. The Contractor would review clinical protocols and provide recommendations concerning study design, primary and secondary endpoints, power calculations and sample size. The contractor would also design case report forms, write procedure manuals for study implementation, perform all programming for data management and analysis and generate reports for studies conducted under a variety of contract and grant mechanisms. The contractor provides training to site staff for on-line enrollment and randomization of study subjects, remote electronic data entry into the web-based data management systems. A contractor must also have the capability to develop and manage interfaces among existing data systems and maintains numerous websites. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: The ability to collect, manage and control the quality of clinical and laboratory data; The ability to design, manage, update and ensure secure access to clinical study materials and data in real time; The ability to design, manage, update and ensure secure access to Clinical Study Website(s); The ability to carry out statistical design and analysis functions; The ability to design and manage an electronic specimen tracking system; The ability to provide clinical sites training, assessment and technical assistance; And the education, training, experience, expertise, qualifications, including, statistical leadership for the design, development, implementation, and analysis of all phases of clinical trials for the evaluation of candidate vaccines of the proposed Principal Investigator. It is an estimated that approximately 40.75 FTEs will be required for the performance of this project over a 7 year period of performance. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit two (2) copies of their capability statement, addressing the areas above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by no later than 4:00PM local time on September 5, 2006. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity). NO COLLECT CALLS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL. See NUMBER NOTE 25.
- Record
- SN01120841-W 20060823/060821220311 (fbodaily.com)
- Source
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