SOURCES SOUGHT
A -- Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT)
- Notice Date
- 7/14/2008
- 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
- SOU-NIAID-DAIT-NIHAI2008026
- Response Due
- 8/4/2008
- Archive Date
- 8/6/2008
- Point of Contact
- Deborah J Blyveis,, Phone: 301-594-7211, David T Lisle,, Phone: 301-451-2617
- E-Mail Address
-
blyveisd@niaid.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. The Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) 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-supported autoimmune disease clinical trials (ADCT) and associated mechanistic studies being conducted by two cooperative groups: The Autoimmunity Centers of Excellence (ACE) program is designed to accelerate the discovery, development, and testing of new immunological therapies for autoimmune diseases. This program fosters collaborations between basic and clinical scientists and supports cooperative single- and multiple-site Phase 1 and 2 clinical trials, as well as associated mechanistic studies. It was established in 1999 and expanded in 2004 to the current 9 sites with a total annual budget of $11.6 million. Since 2004, 13 protocols have been developed or are in development; of these 6 protocols have initiated enrollment and 3 are in follow-up or have been completed. The program will be renewed in FY 2009 (RFA-AI-08-010; http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-08-010.html) under the co-sponsorship of NIAID, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS), and the NIH Office of Research on Women’s Health. The renewed program is expected to be comparable in size to the current program. The Stem Cell Therapy Consortium (hereinafter referred to as “Consortium”) was created in 1999 through the award of several contracts to study hematopoietic stem cell transplantation (HSCT) for the treatment of autoimmune diseases (http://www.niaid.nih.gov/contract/archive/9931rfp.htm). The contracts resulted in the opening and active enrollment of clinical protocols using high dose immunosuppressive therapy (HDIT), followed by HSCT for the treatment of Severe Systemic Sclerosis (SSC) and Multiple Sclerosis (MS). In addition to clinical outcomes, mechanisms of disease, remission and relapse are evaluated as part of these studies. The SSC trial is a Phase II/III pivotal trial evaluating safety and clinical efficacy in subjects with severe, rapidly progressive systemic sclerosis. (See http://clinicaltrials.gov/ct2/show/NCT00114530.) The Phase II single arm MS trial focuses on safety and the assessment of biological activity using MRI measures and clinical outcomes. (See http://clinicaltrials.gov/ct2/show/NCT00288626.) The initial SACCC-ADCT contract was awarded to Rho Federal Systems, Inc. in 2002 (Contract Number N01-AI-25481) and has served to provide a broad range of clinical research support services to the ACE and the Consortium networks. Under this contract, those services will be continued and will also be expanded to provide support for DAIT-funded investigators conducting autoimmune disease clinical trials (ADCT) outside the ACE and Consortium networks through a variety of mechanisms, for example, the NIAID R34/U01 mechanism (http://www.niaid.nih.gov/ncn/clinical/R34.htm). The contract will provide Statistical and Clinical Coordinating Center support for autoimmune disease clinical trials including the activities of the ACE and Consortium. It is anticipated that up to one cost reimbursement completion type contract will be awarded for a period of seven years, beginning approximately in July 2009, with an anticipated annual total effort of approximately 16.0 FTEs per annum for the seven year period. Potential sources must demonstrate and document the following in their capability statements: The Contractor shall establish and manage the SACCC-ADCT to provide statistical, clinical, technical, regulatory and administrative support for autoimmune disease clinical trials and associated mechanistic studies, including support for the following: (1) statistical design and analysis, including interim and final analyses of study data; (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; and (8) establishment and management of a repository for biological specimens. In addition, technical and administrative support shall be provided for the ACE Steering Committee and the Consortium Operations 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 including 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 August 4, 2008. 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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