SOLICITATION NOTICE
A -- Clinical Research Operations and Management Support (CROMS)
- Notice Date
- 4/16/2009
- 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
- RFP-NIAID-DMID-NIHAI2009052
- Archive Date
- 8/14/2009
- Point of Contact
- Frank Vidergar,, Phone: 301-402-1490, Michael Finn,, Phone: 301-496-3699
- E-Mail Address
-
vidergarf@niaid.nih.gov, finnm@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the 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 Microbiology and Infectious Diseases (DMID), has a requirement for the provision of clinical trials management support services. The evaluation of new and improved vaccine and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, Phase 3, and Phase 4 clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, including: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines and therapeutics against potential agents of bioterrorism, including NIAID Category A, B and C priority biodefense pathogens and toxins (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm), and to meet critical public health needs and opportunities for emerging and re-emerging infectious diseases. The purpose of this contract is to provide clinical trials management support services to DMID and DMID-supported investigators. Activities include a web-based clinical trials management system; clinical site assessment, preparation and monitoring; and centralized safety monitoring and document management. Offerors should have the qualifications and experience, and capability to perform this requirement for more than 200 active clinical trials at both domestic and foreign sites, with particular attention to the appropriateness and adequacy of organizational experience, proposed plans and procedures, availability of personnel, and understanding of problems and deficiencies for a variety of clinical trial support functions, including: a. safety monitoring, including proposed safety reporting systems, tracking and handling of serious adverse events (SAEs); b. planning and conduct of clinical site monitoring and reporting; c. planning and conduct of pre-study activities, including clinical site assessments; development and implementation of clinical site Quality Management Programs; and receipt, assessment and maintenance of essential regulatory documentation; d. protocol development support services, including the development of clinical protocols and protocol-related documents; e. establishment and maintenance of a centralized data reporting system to track all clinical support service activities, including: SAE data and reporting; quality management activities; protocol development activities; site essential documentation activities; and metrics for all supported clinical trials (e.g., protocol accrual, site visits, SAEs, etc); f. development and implementation of a Quality Assurance and Quality Control plan to ensure clinical sites comply with domestic and country-specific regulations governing human subjects research; and g. development of annual IND reports, and final clinical study reports. h. development and implementation of training programs for clinical site personnel regarding the conduct of clinical trials. It is anticipated that one cost reimbursement, term type contract will be awarded for a 1-year Base Period plus six 1-year Options for a possible total period of performance of 7-years beginning on or about March 31, 2010. A total level of effort of 102.45 FTEs per year (213,096 total direct labor hours per year based on a Work Year of 2080 hours) for a total period of performance of seven years (Base period plus six, one-year Options) is required. In addition, during any year of the contract, contractors must also be able to respond to requests to provide additional effort based on the exercise of Options in increments of 2 FTEs, 5 FTEs or 8 FTEs, up to a maximum of 28 FTEs per year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about April 30, 2009, and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=6da5c3635f1aae6a740b76882724d742&tab=core&_cview=1)
- Record
- SN01795598-W 20090418/090416223251-6da5c3635f1aae6a740b76882724d742 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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