SOURCES SOUGHT
A -- Atopic Dermatitis Research Network: Statistical and Clinical Coordinating Center (ADRN SACCC)
- Notice Date
- 3/5/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- 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, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIHAI2009063
- Archive Date
- 4/10/2009
- Point of Contact
- MyLinh Pham,, Phone: 301-496-0993, David T Lisle,, Phone: 301-451-2617
- E-Mail Address
-
phamm@exchange.nih.gov, dlisle@niaid.nih.gov
- Small Business Set-Aside
- N/A
- 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 A 100% SMALL BUSINESS SET-ASIDE. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. ALL SMALL BUSINESSES ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 employees. Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research focusing on immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents. This requirement for the Statistical and Data Coordinating Center (SDCC) for the Atopic Dermatitis Research Network provides critical services for the design, implementation, oversight (including regulatory support and compliance, safety and clinical site monitoring and reporting, training, and distribution and quality control of study products), and analysis of DAIT, NIAID-supported Atopic Dermatitis Research Network clinical studies and clinical trials and associated mechanistic studies being conducted by this group. The purpose of the Atopic Dermatitis Research Network (ADRN) is to study the defense mechanisms of the skin, with research focused on atopic dermatitis (AD) and its association with both immune and skin barrier defects (compared to non-atopic individuals). Specific research areas may include the defects resulting in susceptibility to eczema vaccinatum (EV) and eczema herpeticum (EH), and to colonization and infection with Staphylococcus aureus (SA) (including methicillin-resistant Staphylcoccus aureus, MRSA), and responsiveness of AD subjects to vaccines. It is anticipated that research conducted within the ADRN will utilize state of the art techniques to measure immune responses and skin barrier function, and will capitalize on new scientific opportunities and advancements in the field. The ADRN will support multi-disciplinary teams that include qualified personnel committed to the project in areas proposed. This is likely to include immunologists, virologists, bacteriologists, geneticists, dermatologists and allergists. This Network was originally established as the Atopic Dermatitis and Vaccinia Network (ADVN), consisting of three contracts: a Clinical Studies Consortium, an Animal Studies Consortium and a Statistical and Data Coordinating Center These three contracts were originally funded from 2004-2009, and the contracts were then extended until 2010. The ADVN has been focused on the pathogenesis of EV, with the ultimate goal of reducing the severity of EV, but the new solicitation extends the scope of the Network to the research areas described above. The initial ADVN SDCC contract was awarded to Rho Federal Systems, Inc. in 2004 (Contract Number HHSN26620040033C ) and has served to provide a broad range of clinical research support services to the ADVN. Under this contract, those services will be continued and will also be expanded to provide support for the expanded research areas of the new Atopic Dermatitis Research Network. Potential sources must demonstrate and document their ability to perform the following in their capability statements: The Contractor shall establish and manage the ADRN SACCC to provide statistical, clinical, technical, regulatory and administrative support for Atopic Dermatitis Network clinical studies and clinical trials and associated mechanistic studies, including support for the following: (1) statistical design and analysis, including interim and final analyses of study data from clinical studies and clinical trials, as well as any animal studies that are performed; (2) data collection, management, quality assurance and reporting; (3) regulatory activities, including compliance with Federal and country-specific regulatory requirements and current Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) guidelines for research involving human subjects; (4) safety oversight and reporting, including support for the activities of independent Data and Safety Monitoring Boards (DSMBs) and other safety oversight structures; (5) clinical site monitoring and training for clinical site personnel; (6) preparation of study products; (7) distribution and quality control of study products; (8) continuation, expansion and management of a Registry of subjects with AD and subsets of AD subjects, and (9) computer tracking support for a repository for biological specimens. In addition, technical and administrative support shall be provided for the ADRN Steering Committee. Capability statements submitted as a result of this announcement should demonstrate the offerors’ qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by March 26, 2009. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked.
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