SOLICITATION NOTICE
A -- CLINICAL SITE AND STUDY MONITORING
- Notice Date
- 10/24/2008
- Notice Type
- Presolicitation
- 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-NIHAI2008045
- Archive Date
- 4/22/2009
- 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
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS, as the Investigational New Drug (IND) Application sponsor for a large number of DAIDS-funded clinical trials, has a requirement to monitor clinical trials to ensure compliance with DAIDS, domestic and country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS, as the Investigational New Drug (IND) Application sponsor for a large number of DAIDS-funded clinical trials, has a requirement to monitor clinical trials to ensure compliance with DAIDS, domestic and country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. The NIAID, Division of AIDS, is seeking a contractor to provide comprehensive clinical site and study monitoring services for the NIAID/DAIDS extramural clinical trial research portfolio. The scope of activities to be performed includes (a) site initiation visits prior to clinical trial implementation to ensure compliance with DAIDS, U.S. and, where appropriate, country-specific regulatory requirements and guidelines; (b) 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; (c) 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; (d) site closeout visits to ensure appropriate completion of clinical trials, storage of clinical records and disposition of investigational products; (e) preparation of written reports of all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial actions; (f) the development and implementation of 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; (g) the development and implementation of a training plan for site monitors on staff and new hires and for evaluating the effectiveness and efficiency of training activities conducted; (h) collaboration and coordination of clinical site and study monitoring activities and data generated through these activities with multiple other NIAID/DAIDS clinical research support contractors and HIV/AIDS Clinical Trials Network components; and (i) the development and implementation of 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. It is anticipated that one cost reimbursement, completion type contract will be awarded for a seven-year period of performance beginning on or about December 4, 2009. In addition to the above 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 staffing, management, oversight and additional facilities and equipment required for: Option 1 – Clinical Site and Study Monitoring for a Phase IIb/III Vaccine Clinical Trial; Option 2 – Clinical Site and Study Monitoring for a Phase IIb/III Microbicide Trial; Option 3 – Clinical Site and Study Monitoring for Phase IIa Vaccine Clinical Trials; and Option 4 – Clinical Site and Study Monitoring for Phase IIa Microbicide Clinical Trials. It is estimated that the provision of FTEs will be approximately as follows: 77.0 FTEs for the Base Period; 8.15 FTEs for Option 1 for a period of five years; 4.65 FTEs for Option 2 for a period of five years; 8.15 FTEs for Option 3 for a period of three years; and 4.65 FTEs for Option 4 for a period of three years. The NAICS Code is 541712 with a size standard of 500 employees. All responsible sources may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about December 8, 2008, and may be accessed through FedBizOpps http://www.fedbizopps.gov/ and the NIAID Office of Acquisitions (OA) homepage at http://www.niaid.nih.gov.contract/rfps.htm. No collect calls will be accepted. No facsimile or email transmissions will be accepted. Any responsible offeror may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=198edbaa3a040f4c8c4afecfd26482ae&tab=core&_cview=1)
- Record
- SN01696317-W 20081026/081024215507-198edbaa3a040f4c8c4afecfd26482ae (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |