SOLICITATION NOTICE
A -- Clinical Research and Operations Management Support (CROMS)
- Notice Date
- 11/20/2013
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-DE-2014-09-CM
- Point of Contact
- Cornelius Moore, Phone: (301) 435-0343
- E-Mail Address
-
mooreco@mail.nih.gov
(mooreco@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The National Heart, Lung, and Blood Institute anticipates the issuance of a request for proposals (NHLBI-CSB-DE-2014-09-CM) on or about December 6, 2013, on behalf of the National Institute of Dental and Craniofacial Research (NIDCR). The requirement is to provide comprehensive clinical research operations support, management and data coordinating services for clinical research sponsored by NIDCR's extramural and intramural research divisions. The contract will provide NIDCR with clinical research management support and oversight tools to assist in the effective administration and coordination of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study design, study execution, data management and analysis, and regulatory compliance. Specific tasks performed will vary by clinical study and clinical site. As part of its overall research mission, the National Institute of Dental and Craniofacial Research (NIDCR) supports clinical research on the causes, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. These studies, conducted extramurally through the funding of research grants as well as within the intramural research program, include Phase I-III clinical trials as well as population-based, observational, and natural history studies. NIDCR's extramural program has an extensive clinical research portfolio that covers a broad range of clinical efforts. Studies span small, short-term, pilot evaluations involving a single domestic site, to large, multi-year, multi-site clinical studies conducted both domestically and internationally. They include preventive, diagnostic, and therapeutic interventional clinical trials as well as observational clinical studies. Intramural studies are generally performed in NIH's Clinical Center and include both outpatient and inpatient studies, although some studies are multi-center and include clinical sites outside of the Clinical Center. The current clinical research and operations management support (CROMS) contract (HHSN268200800017C) has centralized a number of oversight and management activities such as study tracking, data and safety oversight, and study monitoring. This approach has allowed some studies to be managed by a program specific coordinating center. Management of other studies has been undertaken by the current CROMS contract in a tailored, study-specific approach. This management approach offers flexibility to meet the needs of different extramurally funded programs. For clinical studies conducted in the intramural research program, unique, tailored arrangements are supported by each study. Coordination across these various entities as well as centralized operations support and oversight through clinical monitoring and safety oversight programs are managed by the current CROMS contract. Currently, the CROMS contract provides protocol writing and development services to nearly 20 studies, clinical site monitoring services for approximately 40 studies, data management services for 11 studies, and regulatory support to seven studies. Although NIDCR staff have expertise to assist with various aspects of study design and interpretation/evaluation of study results, these resources are finite. Through the retirement of a senior staff member, even fewer in-house resources are currently available to bolster the clinical coordination efforts needed to establish and maintain an efficient and high-quality clinical research program. Given the growing complexity and size of NIDCR's clinical research program, including the extramural program's focus on product development and biomarker studies, along with the growing number of intramural interventional clinical trials, there is a clear need for a centralized, standardized and cost-effective approach for NIDCR clinical research oversight and management. This announcement is not a request for proposals (RFP) and, although one award is anticipated, the Government is not committed to award a contract pursuant to this announcement. The requirement will cover 60 months and a "Cost-Reimbursement-Completion" type contract is being considered. The ultimate contract type and funding mechanism will be determined by the NHLBI, based on what fits the project's goals and the available funding. The RFP will be available on the FEDBIZOPPS website at http:fedbisopps.gov. Potential Offerors are responsible for downloading the RFP and any/all attachments. It is also Offerors' responsibility to monitor the FEDBIZOPPS for any amendments to the RFP. It has been determined that this acquisition will be set aside for small business concerns under the North American Industry Classification System (NAICS) code 541711.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-DE-2014-09-CM/listing.html)
- Place of Performance
- Address: Office of Acquisitions, 6701 Rockledge drive RKL2/6100, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03237647-W 20131122/131120234255-36256159345562ef32cbbf6b5cbe918f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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