SOURCES SOUGHT
A -- Clinical Coordinating Center for NIDA Clinical Trials Network
- Notice Date
- 9/9/2004
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Bethesda, MD, 20892
- ZIP Code
- 20892
- Solicitation Number
- Reference-Number-5-2208
- Response Due
- 9/24/2004
- Archive Date
- 10/9/2004
- Point of Contact
- Pedro Godinez, Contract Specialist, Phone 301.443.6677, Fax 301.443.7595, - Kenneth Goodling, Contracting Officer, Phone (301)443-6677, Fax (301)443-7595,
- E-Mail Address
-
pg186o@nih.gov, kg25d@nih.gov
- 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 clinical coordinating support for multiple and simultaneously-running multi-site clinical trials conducted under the National Institute on Drug Abuse Center for the Clinical Trials Network (CCTN). Actual clinical trials will not be conducted under this contract. These activities will support studies carried out under cooperative agreements (U-10) with Regional Research and Training Centers (RRTCs) located across the nation. The trial studies include behavior, pharmacological, and integrated therapies in Community-based Treatment Programs (CTPs). While specific site locations may change, the Nodes for these clinical trials and their Community Treatment Providers are nationwide. The specific requirements include: 1. Providing support for regulatory functions and requirements; 2. Reviewing and monitoring protocol implementation; 3. Providing training to research staff; 4. Supplying pharmaceutical services and clinical support; 5. Providing drug testing and analytical laboratory services; 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 efficient and responsive facilities and personnel to support a wide range of clinical trial administrative services and related services for multiple and simultaneously-running multi-site clinical trials. Knowledge and experience of current regulatory and training requirements are necessary to verify that sites remain in regulatory compliance throughout the trial. Site staff training on various aspects of clinical trials such as, Good Clinical Practice (GCP), AE/SAE reporting procedures, CTN?s standard procedures and NIH required certifications for the protection of human subjects is required. NIDA will review experience in monitoring proper paperwork submittals and ensuring timeliness. In addition, Quality Assurance experience in monitoring sites before, during and after the trials is necessary. As required, this organization will coordinate and assist NIDA?s Data Center (third party) in the development of the databases and also will establish correct protocols for transmission. 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 clinical trial administrative services support 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 Clinical Coordinating 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 September 24, 2004 to the NIDA Contracting Officer.
- Record
- SN00668651-W 20040911/040909211818 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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