SOURCES SOUGHT
A -- STATISTICAL AND DATA COORDINATING CENTER (SDCC): NIAID IMMUNE TOLERANCE NETWORK AND ASTHMA AND ALLERGIC DISEASES COOPERATIVE RESEARCH CENTERS
- Notice Date
- 4/25/2007
- 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
- RFP-NIH-NIAID-DAIT-08-10
- Response Due
- 5/9/2007
- Archive Date
- 6/1/2007
- Description
- The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), intends to recompete a requirement for capabilities and facilities to establish and manage a Statistical and Data Coordinating Center (SDCC) to support NIAID sponsored clinical research programs in allergy/asthma, autoimmune, and transplant-related diseases. Under the current contract to the PPD Corporation (HHSN266200400075C), the SDCC has served to provide a broad range of clinical research support services to the Immune Tolerance Network (ITN). Under this contract, the Statistical and Data Coordinating Center (SDCC) will support each of the following two research programs: 1. The Immune Tolerance Network (ITN) was established in 1999 and is currently under a contract to the University of California, San Francisco. The overall goal of the ITN is to accelerate the evaluation of promising approaches for the induction and maintenance of immune tolerance in four clinical areas: solid organ transplantation, islet cell transplantation, autoimmune diseases, and asthma and allergic diseases. 2. The Asthma and Allergic Diseases Cooperative Research Centers (AADCRCs) were established in 1971 to promote integrated, multidisciplinary basic and clinical research on the immunologic mechanisms underlying the onset and progression of asthma and allergic diseases. The overall goal of this program is to improve the diagnosis and treatment of asthma and allergic diseases, and to provide a rational foundation for the development of effective therapeutic and prevention strategies. The Contractor shall serve as the SDCC for clinical and non-clinical research activities carried out by the ITN with the responsibility for a broad range of support functions, including: statistical design and analysis; clinical data collection, storage, management, quality control, reporting and associated training for clinical site personnel; safety oversight; preparation of study-related materials; and clinical study website development and maintenance. In addition, the Contractor shall also support the AADCRCs by providing assistance in the statistical design, analysis and final reporting for some of the AADCRC clinical trials and mechanistic studies upon request of the Project Officer. This will typically involve a multi-center effort and a collaborative relationship with clinical investigators, other supporting contractors, and DAIT/NIAID staff. (Note: Although the ITN generates both clinical and mechanistic data from each trial, the scope of SDCC statistical functions is limited only to clinical data as specified in each protocol. Statistical design and analysis of mechanistic data and combined data from both clinical trials and mechanistic studies will be performed collaboratively by the ITN Clinical Trials Group and the ITN Bioinformatics Group). The contract will be funded for a base period of six (6) years to provide SDCC support for the research activities of the ITN and the AADCRCs. In addition, the Government reserves the right to exercise three (3) options: Option 1 provides for an extension of the contract for one (1) additional year to continue the SDCC support services specified in the base period for both research programs; Option 2 provides for additional SDCC support for data collection, storage, management, quality control and reporting for some AADCRC studies upon request of the Project Officer; and Option 3 provides SDCC support for other DAIT-sponsored research programs and projects involving clinical research on immune-mediated diseases, including asthma and allergic diseases, solid organ, tissue and cell transplantation, and autoimmune disorders. These other programs and projects that may be supported under Option 3 include new individual clinical trial grants and existing and future clinical research programs/networks and projects awarded by DAIT. It is anticipated that up to one cost reimbursement completion type contract will be awarded for a period of six years, beginning approximately July 31, 2008, with an anticipated total effort of approximately 25.5 FTEs for the Base period, zero additional FTEs for Option #1, 6 additional FTEs for Option #2, and 3 additional FTEs for Option 3. The anticipated total effort for the Base period and if Options 1, 2, and 3 are exercised is approximately 34.5 FTEs. Potential sources must demonstrate and document the following in their capability statements: The support services to be provided by the contractor under this contract include the following: 1) statistical expertise, experience, and leadership of a statistical and data coordinating center (SDCC) for clinical investigator networks and programs of comparable size and complexity to the ITN and the AADCRC including domestic and/or international clinical trials for safety and efficacy or mechanistic studies; 2) statistical expertise for feasibility assessments of study design issues for concept proposals, full applications, clinical protocols, and/or mechanistic and surrogate/biomarker studies, as well as preclinical safety study evaluations; 3) statistical assistance in the development of statistical designs and statistical analysis plans for clinical protocols; 4) statistical analyses of interim and comprehensive final clinical trial data including descriptive as well as univariate and multivariate inferential analyses; 5) electronic dataset transfer capabilities; 6) computerized systems for the collection, management, storage, security, reporting, and quality control of study data including electronic/internet-based systems to accommodate on-line subject enrollment and randomization; 7) assistance with preparation of study-related materials such as Manuals of Operations, investigator brochures, electronic or paper case report forms, and/or source documents, tracking logs, or order forms for clinical supplies; 8) development and maintenance of protocol web sites to share information and study materials with study sites and to provide DAIT and the Investigators with real-time study information, such as overall and site-specific accrual, demographics, adverse events, queries, and deviations; 9) providing training to clinical site staff to access the data system, perform remote data entry; 10) statistical and medical writing assistance for the preparation of regulatory submissions including IND applications with respect to statistical design and analysis issues/plans, including pre-IND briefing packets, annual reports, interim clinical study reports, and assistance with inquiries, meetings, and/or teleconferences with regulatory health authorities; 11) comprehensive data management and reporting services for operating and managing computer-based systems at a central facility for data collection, storage, real-time electronic notification capabilities, and management (database 1) of all clinical and laboratory research data including adverse events (AEs) for clinical and non-clinical studies conducted by the ITN; 12) comprehensive safety data collection and reporting (database 2) capabilities for reporting, tracking, and archiving of SAEs for all ITN studies conducted under the contract; 13) serving as a repository to store (archive) all data from databases 1 and 2 for all completed studies over the contract period of performance; 14) Quality control of all data (databases 1 and 2) to monitor for accuracy, completeness, and timeliness of the data submitted from participating centers for 100% of the study data; provide for security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries and/or catastrophic loss of study data; 15) Safety Oversight and Reporting functions including: assist in the development of data and safety monitoring plans for each trial; assist in the preparation and submission of interim and final study data for review by NIAID-established safety oversight structures; assist in the documentation of written summaries of recommendations from NIAID-established safety oversight structures; and 16) Establish and operate a Safety reporting center for all ITN clinical trials;17) Establish, maintain, and operate one or more internet-based collaboration portals; 18) Integrated project management capabilities; and 19) Coordinate and collaborate with DAIT/NIAID-staff, investigators, and other DAIT-supported clinical research support services contractors. 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: TECHNICAL EVALUATION CRITERIA: CRITERIA WEIGHT 1: TECHNICAL PLAN/APPROACH 70 2: SCIENTIFIC AND TECHNICAL PERSONNEL 25 3: FACILITIES, EQUIPMENT AND OTHER RESOURCES 20 4: PROJECT MANAGEMENT 15 TOTAL POSSIBLE WEIGHT: 130 1 EVALUATION OF OPTIONS 20 Other Factors: 1 PAST PERFORMANCE FACTOR 20 TOTAL POSSIBLE WEIGHT (with Options): 170 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 May 9, 2007. 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 (see Government-Wide Numbered Note 22).
- Record
- SN01280853-W 20070427/070425220507 (fbodaily.com)
- Source
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