SOURCES SOUGHT
A -- NIAID Division of Allergy, Immunology and Transplantation: Clinical Site Monitoring Center
- Notice Date
- 5/24/2010
- 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
- HHS-NIH-NIAID(AI)-SBSS-10-032
- Archive Date
- 6/11/2010
- 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
(phamm@exchange.nih.gov, dlisle@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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; HUBZone small businesses; service-disabled, veteran-owned 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 NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 employees. Description 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 programs and individual research projects to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents. DAIT's largest clinical research program is the Collaborative Network for Clinical Research on Immune Tolerance Network (ITN). A critical component of the ITN's mission involves the design and conduct of clinical research studies, including Phase I-IV clinical trials of investigational approaches intended to lead to a functional state of immune tolerance in three clinical areas: autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells. The purpose of this contract is to provide DAIT with continued clinical site monitoring services for the ITN, and expand the scope of clinical site monitoring services provided to include DAIT-supported, investigator-initiated clinical research studies conducted under cooperative agreement grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis. DAIT provides comprehensive clinical site monitoring services to fulfill its responsibilities as the funder and/or sponsor of clinical research studies conducted by ensuring compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and E6 International Conference on Harmonization Good Clinical Practices (ICH/GCP). It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Option 1 - additional Years 2 through 10) to be approximately 10.7 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 10% over the base requirement which can be exercised up to 10 times per contract year. An Option for electronic data submission to an internal DAIT-wide system will be included as well. The Government estimates a 10% increase in the total level of effort for this optional activity during the applicable 6-month period. Potential sources must demonstrate and document the following in their capability statements: Offerors should have the qualifications, experience, and capability to perform site monitoring requirements for more than 30 active clinical research studies, including trials, at both domestic and foreign sites, single- and multi-site, with particular attention to the appropriateness, adequacy of experience, and understanding of a variety of clinical research monitoring functions, including: • establishment and implementation of a clinical site monitoring system, including (a) site establishment visits, (b) interim site monitoring visits, (c) remedial and for cause site visits, (d) site and study closeout visits, (e) laboratory and specimen audits, (f) the provision of clinical site monitoring reports, (g) assistance to clinical sites in preparing for audits from Regulatory Health Authorities, and (h) the development, implementation and updating of Standard Operating Procedures. • the development and implementation of training programs for clinical site personnel and site monitors, including assessments of the quality and thoroughness of the training conducted. • the operation, management, maintenance and updating of a centralized CSMC Data Management and Reporting System. • coordination and collaboration with other DAIT clinical research support contractors. • development and implementation of a Quality Assurance/Quality Control Plan. Contractors must be able to clearly convey their experience and/or ability to perform the following tasks: • Conduct site initiation visits prior to clinical trial implementation to ensure compliance with DAIT, U.S., and, where appropriate, country-specific regulatory requirements and guidelines. • Conduct routine site monitoring visits for active clinical trials to ensure compliance with DAIT, U.S. and where appropriate, country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. • Conduct specialized site monitoring visits for a variety of purposes, including regulatory audits, assessments of overall and protocol-specific research pharmacy operations and management of investigational products, and remedial or for cause site visits to implement and ensure adherence to corrective actions required to address site or study deficiencies identified through routine site monitoring. • Conduct site closeout visits to ensure appropriate completion of clinical trials, storage of clinical records and disposition of investigational products. • Prepare written reports on all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial actions. • Develop and implement Standard Operating Procedures for the conduct of clinical site and study monitoring functions, including the components to be reviewed/assessed and the processes to be used for each type of site visit. • Develop and implement a training plan for site monitors on staff and new hires and for evaluating the effectiveness and efficiency of training activities conducted. • Collaborate and coordinate clinical site and study monitoring activities and data generated through these activities with multiple other DAIT clinical research support contractors and DAIT Clinical Research Network components. • Develop and implement a Quality Assurance/Quality Control (QA/QC) Plan to ensure the efficient and effective performance of monitoring functions and the appropriate management of the project. • Ability to expand staffing from the base period if any of the Options are exercised as directed by DAIT. 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 inclusive of an international component. 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. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort which includes: (1) a summary list of similar work previously performed for being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Project Director, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. 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 June 10, 2010. 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. 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 received, 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).
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