SOURCES SOUGHT
A -- Data and Statistics Center for the NIDA Clinical Trials Network
- Notice Date
- 11/21/2008
- 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 on Drug Abuse, 6101 Executive Boulevard, Room 260 - MSC 8402, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- 9-0011
- Response Due
- 12/5/2008 4:30:00 PM
- Point of Contact
- Pedro M Godinez,, Phone: 301.443.6677, Kenneth E Goodling,, Phone: (301)443-6677
- E-Mail Address
-
pg186o@nih.gov, kg25d@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Drug Abuse (NIDA) seeks capability statements from qualified Small Businesses (NAICS 541710, small business size standard is 500 employees). The requirements include data management and statistical analysis services in support of multiple and simultaneously-running multi-site clinical trials conducted within the NIDA Clinical Trials Network (CTN). While the specific site locations may change, the Nodes for these clinical trials and their Community Treatment Providers are nationwide. The sites represent a variety of treatment traditions including pharmacological as well as behavioral and other psychosocial interventions. Actual clinical trials will not be conducted under this contract. Rather, activities will support the trials carried out under cooperative agreements (U-10) with Regional Research and Training Centers (RRTCs) located across the nation. The requirements include: 1) establishing and administering systems for the collection, management and storage of study data; 2) designing and performing all statistical analyses; 3) reviewing and monitoring the quality of study data; 4) monitoring trial progress; 5) preparing reports for the Data and Safety Monitoring Board; 6) providing support for protocol development; 7) participating in relevant committee and subcommittee meetings and conference calls; and, 8) providing other expert consultation and support services as needed. Interested organizations must show experience in establishing and maintaining state-of-the-art, efficient, responsive and secured systems for the collection, storage, management, quality assurance and reporting of this type of study data, including data extracted in a foreign language (e.g. Spanish). Experience must also include effective maintenance of computer software and hardware for these activities as well as experience in developing a web-based system (e.g. Livelink) that provides document management for secured electronic communications, as well as experience in coordination and collaboration with other parties in the development of large and complex databases and other tools to meet the reporting requirements. In addition, capabilities must include ability to meet the requirements needed in tracking and transmitting data across systems, as the actual project will entail meeting the requirements for submitting data to the National Library of Medicine (NLM) ClinicalTrials.gov website through NIDA's Clinical Trials Portfolio System (CTPS) (http://www.nida.nih.gov/CTN/Data.html). Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects, specific Data and Statistics Center work performed, and work in the field of drug abuse; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as principal investigator and/or project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to develop the databases and statistical reporting capabilities in support of a Data Center. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a request for proposals. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent or the Government's use of the information. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Please submit written capability statements by December 5, 2008 to the NIDA Contracting Officer.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=32a16237cec624c155698a36cf1ecbd5&tab=core&_cview=1)
- Record
- SN01708614-W 20081123/081121215135-32a16237cec624c155698a36cf1ecbd5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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