SOURCES SOUGHT
A -- NIAID/DAIDS Clinical Research Auditing
- Notice Date
- 8/27/2008
- 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
- NIAID-DAIDS-A1009
- Point of Contact
- Jason Bell,, Phone: 301-496-0612
- E-Mail Address
-
belljas@niaid.nih.gov
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE NIAID/DAIDS CLINICAL RESEARCH AUDITING Type of Requirement _X_ New Requirement ___ Re-competition (Contract No.:_______________) ___ Expansion of (Contract/RFP No.:______________) Place of Performance ___ Place of performance is unknown at this time _X_ Place of performance is known. Address or general location: Work under this contract will be performed in the U.S. and internationally, in approximately 40 countries Recompetition (if applicable) NA Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612 General Information Document Type: Sources Sought Notice Solicitation Number:Reference Number NIAID-DAIDS-A1009 Posted Date: Original Response Date: September 11, 2008 Current Response Date: September 11, 2008 Original Archive Date: Current Archive Date: Classification Code:A -- Research & Development NAICS Code:541712 –Research and Development in the Physical, Engineering and Life Sciences INTRODUCTION 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: (1) Quality assurance auditing of clinical site monitoring functions performed at clinical research sites participating in NIAID/DAIDS-sponsored clinical trials, and (2) independent for cause auditing of NIAID/DAIDS-supported domestic and foreign clinical research sites. Site auditing 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. THE DAIDS, NIAID, WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. BACKGROUND The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to bring an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the advancement of therapies for HIV infection and its complications, and supporting the development of HIV/AIDS vaccines and other prevention measures. NIAID, through a variety of grants and contracts, sponsors Phase I, II, III and IV clinical trials will evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. NIAID currently funds more than 250 clinical trials in over 40 countries at more than 500 domestic and foreign clinical sites. Since its inception in 1987, DAIDS has designed, developed and sponsored extramural Clinical Trials 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 NIAID/DAIDS-funded clinical trials, there is an established requirement for NIAID to monitor clinical trials to ensure compliance with the protocol and applicable regulations including Title 21 Code of Federal Regulations (CFR) Part 312 and Human Subjects Protection Title 45 CFR Part 46. Clinical trials are also monitored in accordance with the E6 International Conference on Harmonisation Good Clinical Practices (ICH/GCP). At present, selected NIAID/DAIDS clinical site monitoring visits and related reports are audited through a component of the current NIAID/DAIDS Clinical Research Services (CRS) contract number N01-AI-50022 to ensure the completeness and accuracy of site monitoring services. By means of this new solicitation NIAID will establish a separate and independent contract to provide (1) quality assurance auditing of clinical site monitoring functions performed at clinical research sites participating in NIAID/DAIDS-sponsored clinical trials, and (2) independent for cause auditing of NIAID/DAIDS-supported domestic and foreign clinical research sites. It is anticipated that approximately 77 audits over the next seven years will be performed between domestic and international sites. This is estimated at 60 pecent international and 40 percent domestic. 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) development and implementation of Standard Operating Procedures (SOPs) specific to each of the two main auditing functions 2) development and implementation of audit plans specific to each of the two main auditing functions 3) conduct of the following audits (See SOW Exhibit 1): • audits of completed routine and specialized clinical site monitoring visits performed by the clinical site monitoring contractor/entities, and audits of completed remedial and for cause clinical site monitoring visits performed by the clinical site monitoring contractor/entities • independent for cause audits of clinical research sites 4) preparation of comprehensive auditing reports and Corrective and Prevention Action (CAPA) Plans 5) development and implementation of a training plan for auditors 6) coordination and collaboration with other clinical research support contractors and clinical research networks and sites 7) operation and maintenance of a database of contract-generated reports and other information/materials 8) development and implementation of an internal Quality Assurance/Quality Control (QA/QC) Plan and an Integrated Master Project Plan 9) 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/index.asp Teaming Arrangements: All teaming arrangement should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted no later than 3:00 PM, September 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 Jason Bell, Contract Specialist. He can be emailed at the address provided below. 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-A1009. A paper copy can be sent via regular mail at the address provided below. National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions ATTN: Jason Bell 6700 B Rockledge Drive, Room 3230A MSC 7612 Bethesda, Maryland 20892-7612 Email Address: belljas@niaid.nih.gov 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. As previously stated, the Government will not entertain questions regarding this Market Research; however, general questions may be forwarded to the following: Contract Specialist: Jason Bell Email Address: belljas@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.nih.gov
- Web Link
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- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, Maryland, 20892-7612, United States
- Zip Code: 20892-7612
- Zip Code: 20892-7612
- Record
- SN01652817-W 20080829/080827221520-edfbe8492fe37c832526a380f144a6a3 (fbodaily.com)
- Source
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