SOURCES SOUGHT
A -- Clinical Site and Study Monitoring
- Notice Date
- 7/25/2008
- 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 Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- SS-NIH-NIAID-DAIDS-A0905
- Response Due
- 8/11/2008
- Archive Date
- 8/26/2008
- Point of Contact
- Michael Finn,, Phone: 301-496-3699, EileenWebster-Cissel ,, Phone: 301-496-0349
- E-Mail Address
-
finnm@mail.nih.gov, webstere@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- This SOURCES SOUGHT NOTICE is to determine the availability of potential small businesses (e.g., 8(a), service disabled veteran-owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) that can provide: Comprehensive clinical site and study monitoring services for the DAIDS-supported extramural clinical trial research programs and projects, both internationally and domestically. Site monitoring is required to ensure the site is in compliance with Good Clinical Practices (GCP) 21 Code of Federal Regulations (CFR) 312 GCP and Human Subjects Protection 45 CFR 46, and E6 International Clinical Harmonization (ICH) guidelines. DAIDS currently funds more than 250 clinical trials in over 40 countries at more than 500 domestic and foreign clinical sites. The information from this market research will help the National Institute of Allergy and Infectious Disease, Division of Acquired Immunodeficiency Syndrome (DAIDS) plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC. THIS IS STRICLY MARKET RESEARCH. NIAID/DAIDS WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. BACKGROUND The National Institute of Allergy and Infectious Diseases, Division of Acquired Immunodeficiency Syndrome (DAIDS) supports the advancement of therapies for HIV infection and its complications, and supports the development of HIV/AIDS vaccines and other prevention measures. DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. DAIDS has designed, developed and sponsored extramural Clinical Trial Networks, supported investigator-initiated clinical trials, and partnered with other Government and private organizations to assist in carrying out the Division’s scientific objectives. As the Investigational New Drug (IND) Application sponsor for a large number of DAIDS-funded clinical trials, there is an established requirement for DAIDS to monitor clinical trials to ensure compliance with DAIDS, domestic and country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trail data, and assess adherence to protocol-specific requirements. In addition to the functions and services to be provided for the Base Period, up to four Options for expanded services under the contract may be exercised at the discretion of the Government. These Options include clinical site monitoring for up to two additional Phase IIb/III studies and up to six Phase IIa studies. RESPONSE INFORMATION In order to respond to this notice, contractors must be able to clearly convey their experience and/or ability to perform the following tasks: 1.Conduct site initiation visits prior to clinical trial implementation to ensure compliance with DAIDS, U.S., and, where appropriate, country-specific regulatory requirements and guidelines. 2.Conduct routine site monitoring visits for active clinical trials to ensure compliance with DAIDS, 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. 3.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. 4.Conduct site closeout visits to ensure appropriate completion of clinical trials, storage of clinical records and disposition of investigational products. 5.Prepare written reports on all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial actions. 6.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. 7.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. 8.Collaborate and coordinate clinical site and study monitoring activities and data generated through these activities with multiple other DAIDS clinical research support contractors and HIV/AIDS Clinical Trials Network components. 9.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. 10. Ability to expand staffing from the base period if any of the Options are exercised as directed by NIAD/DAIDS. 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 the following: (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 Each response should include the following Business Information: a.DUNS b.Company Name c.Company Address d.Company Point of Contact, Phone and Email address and FAX e.Current GSA Schedule appropriate to this Sources Sought. f.Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the activities set forth in the Statement of Work (SOW). The Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted not later than 4:00 PM, August 11, 2008. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Michael Finn, Contract Specialist. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line Reference: NIH-NIAID-DAIDS-A0905. A paper copy can be sent via regular mail at the address provided below. National Institute of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions ATTN: Michael Finn 6700 B Rockledge Drive, Room 3214 MSC 7612 Bethesda, Maryland 20892-7612 GENERAL INFORMATION This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. Capability statements will not be returned and will not be accepted after the due date.
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