SOLICITATION NOTICE
B -- Special studies
- Notice Date
- 4/20/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
- ZIP Code
- 20892-7663
- Solicitation Number
- 263-2005-Q(DQ)-0036
- Response Due
- 4/25/2005
- Description
- The National Institutes of Health (NIH), Office of Biotechnology Activities (OBA) requires a subject matter expert in the field of Biostatistics to provide expert advice to the work of the Clinical Trial Design Working Group, of the NIH Recombinant DNA Advisory Committee. The OBA has been involved with the exploration of issues such as IC (Institute) variability in Data and Safety and Monitoring Boards (DSMB) operating procedures, best practices in data review and conflict of interest screening. This effort crosses IC lines and is an effort to standardize the various IC?s approach to these issues. The ordering office has identified Dr. Lawrence Friedman as the only source to met the subject requirement (Note: FAR 6:302-1(a)(2) only one responsible source and no other supplies or services will satisfy the agency requirement. The contractor shall provide but shall not be limited to the following services: ?Shall research, gather information and prepare analyses of current issues being explored by the Crpac program. This shall include areas such as adverse event reporting; clinical trial design and clinical monitoring; regulations governing research involving human biological materials; informed consent; third parties, streamlining and standardizing policies and guidelines required for the performance of clinical research. ?Shall plan, organize and provide expert analysis in the area of Biostatistics for a series of workshops and national conferences regarding clinical trial design and clinical trial monitoring issues with initial emphasis on the roles and responsibilities and operating procedures of DSMB. ?Shall participate in and provide expert advise to the work of the Clinical Trial Design Working Group, of the NIH Recombinant DNA Advisory Committee. ?Shall provide expert advice for the senior policy and program staff within the individual NIH IC?s, staff in federal agencies and offices that have responsibilities relative to the oversight of clinical research, including the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the federal agencies that have adopted the Common Rule, as well as patient advocacy and voluntary organizations and other constituencies with a stake in the performance of clinical research. ?The period of performance for completion of this project shall be approximately five months and the work specified herein shall begin fifteen days after award of the purchase order. ?Shall have an in depth and thorough knowledge of the NIH Institutes and familiarity of the various IC approaches to DSMB operating policies and procedures, best practices in data review and conflict of interest screening. ?Shall have an in depth and thorough knowledge of the direction the OBA requires for the issues mentioned above.
- Record
- SN00792543-W 20050422/050421083438 (fbodaily.com)
- Source
-
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