SOURCES SOUGHT
A -- Data, Statistics, and Clinical Trial Support for NIDA (DSC4)
- Notice Date
- 6/12/2013
- 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, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SBSS-14-004
- Archive Date
- 7/11/2013
- Point of Contact
- Ryan C. Cleary, Phone: (301)443-6677, Kenneth E Goodling, Phone: (301)443-6677
- E-Mail Address
-
clearyrc@mail.nih.gov, kg25d@nih.gov
(clearyrc@mail.nih.gov, kg25d@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources under the task categories defined below; (2) whether the capable organizations are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method(s), including whether a set-aside in a specific category is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Institute on Drug Abuse (NIDA) is seeking capability statements from small businesses having in-house capability to support and provide resources in managing and carrying out multiple trials in drug abuse research. We are seeking an organization to provide support for systems, procedures, and expertise in data management, statistical support, and information support and services. The systems will be used to support data collection, data analysis, document management, information exchange, scientific discovery efforts and clinical evaluation of promising new anti-addiction therapies and companion behavioral interventions in order to further NIDA's mission. NIDA conducts single and multi-site clinical trials through grants, contracts and cooperative agreements in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. These studies could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry type trials or surveys. Although no actual clinical trials will be conducted under this requirement, the project activities will support NIDA trials in the following areas: 1. Establish and administer electronic web-based systems for the collection, management and storage of study data 2. Assist in the design of trials, provide support for protocol development and perform statistical analyses, develop statistical sections of protocols, including study design, randomization, power and sample size calculations 3. Review and monitor the quality of study data, perform data audits, perform ongoing data error resolutions, verify laboratory and other clinical data 4. Monitor trial performance and progress, create daily and monthly reports for each trial's performance 5. Prepare reports and hold meetings for the Data and Safety Monitoring Boards (DSMB) 6. Participate in relevant committee and subcommittee meetings and conference calls 7. Provide other expert consultation and support services in fields such as Electronic Health Records, Common Data Elements, and registry trials. The established NAICS code is 541712. 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 similar projects in the area(s) specified above and work in the field of drug abuse; 2) Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions; and 3) Facilities: Availability and description of facilities and equipment required to conduct the type of work required under a specific task area. 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 under these task areas. 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 IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received to provide feedback to respondents with respect to any information submitted. Interested organizations presenting a capability statement must provide the following: 1) company name, address and DUNS number; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes, 5) business size and status; 6) the capability information in response to the requirement and qualification identified in this notice; and 7) small business classification. Please submit written capability statements by June 26, 2013 to the NIDA Contracting Officer.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SBSS-14-004/listing.html)
- Record
- SN03087341-W 20130614/130612235348-8feec73eb72e78ccb812fd4dc402d1e4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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