SOURCES SOUGHT
A -- NICHD International and Domestic Pediatric and Maternal HIV Studies Coordinating Center
- Notice Date
- 10/3/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD-CRMC-SS-13-01
- Archive Date
- 10/17/2011
- Point of Contact
- Lynn L Salo, Phone: 301-435-6962, Elizabeth J. Osinski, Phone: 301-435-6947
- E-Mail Address
-
ls59u@nih.gov, eo43m@nih.gov
(ls59u@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Background: The National Institute of Child Health and Human Development (NICHD) requires logistical, technical, and administrative support to maintain, coordinate, train, monitor and manage a multi-site network of clinical centers conduct¬ing intervention trials and other research on treatment, prevention, diagno¬sis, epidemiology, and natural history of HIV infec¬tion and disease in pediatric, adoles¬cent, and maternal patient popula¬tions, including both domestic and international clinical sites. The NICHD is interested in identifying whether there any interested Small Business Concerns with the requisite capabilities to serve as the NICHD International and Domestic Pediatric and Maternal HIV Clinical Studies Coordinating Center. The Coordinating Center contract currently manages a network of 35 clinical research sites throughout the United States (25) and in Latin America (10) that participate in studies through multiple research networks. Purpose of this Announcement: This is a Small Business Sources sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; 8(a) small businesses, veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification system (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees or less. Project Requirements: The proposed acquisition will involve the following types of activities: 1. Serve as the coordinating center for all aspects of management and monitoring of clinical research sites in the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network. Sites are currently located in the US and Latin America and may also be located in Africa, Asia and other regions during the project period. The NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network ("NICHD Network") has been funded through the NICHD Coordinating Center contract since 1987. The NICHD Network consists of domestic and international clinical sites that enroll study subjects in trials related to preventing and treating HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women, as well as selected clinical trials of gender-specific manifestations of HIV infection in non-pregnant women. The Network enrolls into trials conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network and Adult AIDS Clinical Trials Group (AACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), the NICHD-funded Adolescent HIV Medicine Trials Network (ATN), the Centers for Disease Controls and Prevention (CDC), and Pediatric European Network for Treatment of AIDS (PENTA). Domestically, the Network consists of 25 centers, located in 18 cities, in 10 states/territories (including Puerto Rico); there are ten international clinical trials sites: nine sites in different areas of Brazil, and one in Argentina. It is anticipated that network sites will be recompeted in 2014 and will potentially include sites in Africa, Asia and Eastern Europe in addition to Latin America and the United States. NICHD also supports laboratory-based pathogenesis-oriented research in the context of clinical trials. The Coordinating Center provides support to clinical trials site investigators with special laboratory expertise for the conduct of specialized pathogenesis-based studies in the context of PACTG protocols. The Coordinating Center provides special support to international sites, such as providing specimen transport through a central Coordinating Center contract with World Courier. 2. Perform Site Monitoring of Phase III NICHD-Funded Investigator Initiated International trials in pregnant and non-pregnant women, infants, children and adolescents. As the NICHD international research grant portfolio has increased to include large phase III clinical trials conducted in resource-limited countries, there is an increasing need to ensure that such investigator-initiated trials are conducted ethically, in accordance with Good Clinical Practices, and with attention to human subject safety. The Coordinating Center will conduct site monitoring for selected NICHD grantees conducting large clinical trials to ensure appropriate trial conduct. Anticipated Period of Performance: The anticipated period of performance is five years beginning in about December 2012. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. Small Business organizations must submit Capability Statements in response to this notice and that will be evaluated against the following technical areas of experience and expertise: 1. The NICHD International and Domestic Pediatric and Maternal HIV Studies Coordinating Center requires the ability of the contractor to effectively and flexibly run a very large and complex multi-center international and domestic clinical trials network that implements and manages studies in collaboration with multiple other networks (with the ability to make appropriate modification of data collection and submission to match that of other networks). 2. The contractor must be capable of managing over $30 million in subcontracts with multiple clinical sites, laboratories and other agencies (such as shipping agencies). 3. The contractor must have the ability and capacity, as demonstrated by prior experience, to monitor an average of 30 network clinical trials at multiple domestic and international trials sites as well as monitor selected investigator initiated clinical trials. 4. The contractor must be able to manage at least 50 simultaneous subcontracts. 5. The successful Coordinating Center contractor will have to immediately (within 30 days following contract award) assume ongoing clinical trials work at multiple U.S. and international sites. Thus, an applicant must demonstrate the ability and capacity that they can immediately (within 30 days following contract award) assume responsibility to support 50 subcontracts valued at over $30 million. 6. The contractor will be required to support data systems that interface and interact with data systems used by at least 3 different networks using different data management systems (the AACTG, ATN and IMPAACT). 7. Since the Coordinating Center will manage and monitor clinical trials conducted in highly vulnerable populations - neonates, children, adolescents and pregnant women - that require specific knowledge of federal regulations related to research in these populations and knowledge of the unique characteristics of such populations when conducting research, the contractor is required to have substantial prior experience with HIV-related studies in these populations in order to immediately assume the work of the Coordinating Center. 8. The contractor must demonstrate the ability and have prior experience in training, monitoring and management of clinical trials in the United States and in low-resource settings in Africa, Latin America and Asia. 9. The Contractor must be able to provide personnel, facilities, and other services necessary to maintain and coordinate clinical treatment, prevention, natural history, epidemiologic, and diagnostic research studies at participating centers of studies conducted within the NICHD International and Domestic Pediatric and Maternal HIV Studies Coordinating Center contract. 10. The Contractor must be able to continue the research studies within the NICHD Network described above in addition to new studies requested and approved by NICHD. 11. The Contractor must be able to provide through subcontracts the clinical trial sites and laboratory servic¬es, including drafting, negotiating, executing, administering, monitoring, renewing and/or modifying as needed subcontracts with all current partici¬pating sites and laboratories (domestic and international) and any new clinical centers or laborato¬ries as designated by NICHD, and provide support for subcontracted clinical and laboratory centers of the NICHD network. 12. The Contractor must be able to provide services to assure regulatory compliance for research activ¬ities of sites subcontracted by Coordinating Center for performance of aforementioned studies, including maintaining a communications system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Adverse Experience Reports; plans for acquisition, dis¬tri¬bution, dispensing, handling, administration, and accountability of study drugs; site monitoring for quality assurance of research con¬ducted at all subcontracted clinical and laboratory sites and for selected international clinical trials 13. The Contractor must be able to provide clinical and statistical analysis services, including scientific, techni¬cal, and administrative support for the development, implementa¬tion, and analysis of the specified research, development of data elements and forms, ensure timely and accurate data collection, central data entry, data quality assurance, retrieval of source documentation, and genera¬tion of data and safety monitoring reports; training for staff of subcontracted clinical and laborato¬ry centers in data management proce¬dures; provision for data input, editing, electronic data storage, data¬base management, data retrieval, and statistical analysis; electronic data transmission and electronic mail transmission between Contractor, subcon-tracted clinical and laboratory centers, and collaborating Statis¬tical and Data Analysis Center databases. 14. The Contractor must be able to provide services for implementation and monitoring of clinical tri¬als. at all participating NICHD clinical and laboratory centers and for selected international clinical trials; assuring compliance by sites with all requirements for protocol implementa¬tion, including IRB review and approval prior to protocol initia¬tion, patient consent and confidenti¬ality require¬ments, and Federal bioresearch regula¬tions and requirements for security and confiden¬tiality of research records, and that each relevant clinical site staff member completes annual human subjects training; developing site-specific, protocol-specific budget for each protocol ; training for staff of subcontracted clinical and labo¬ra¬to¬ry centers in procedures for implementation and conduct of specific protocols. 15. The Contractor must be able to provide services for development and review of new and ongoing re¬search activities, including a protocol development team and protocol development plan; draft and edit protocols; maintain necessary documentation for application submissions in compliance with FDA requirements; support for the planning and conduct of meetings of proto¬col committees and subcommittees, data and safety monitoring boards, and investigators; administrative, technical, and logistical support for research activities. 16. The Contractor must be able to provide consultants with specialized expertise related to clinical trial efforts, as required by NICHD. Disclaimer and Important Notes: 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. After a review of the responses receive, a pre-solicitation synopsis and solicitation may be published in federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies (e-mail to ls59u@nih.gov) in addition to four (4) hard copies of their capability statement addressing the areas above (hard copies to be mail to Lynn Salo at the address listed below). Please limit responses to 15 pages or less. These pages exclude resumes. Written capability statements should be received by the Contracting Officer by 3:00PM ten (10) days after publication of this notice. Capability statements must identify the business status of the organization, NAISC along with DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.). No collect calls will be accepted. Inquiries should be directed to: Ms. Lynn Salo, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6962, FAX 301-402-3676, e-mail ls59u@nih.gov. OR, Ms. Elizabeth Osinski, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6947, FAX 301-402-3676, e-mail eo43m@nih.gov.
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