SOLICITATION NOTICE
A -- Biospecimen Contributing Institutions for Research Studies in Cancer Tissue Pre-Analytical Variables - RFP S09148
- Notice Date
- 5/5/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S09-148
- Archive Date
- 7/3/2009
- Point of Contact
- Victoria Barron,, Phone: 301-846-5825
- E-Mail Address
-
barronvl@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- Subcontract Attachment 2 Subcontract Attachment 1 RFP Attachment 3 RFP Attachment 2 RFP Attachment 1 RFP Document The purpose of this procurement is to subcontract with hospital centers, hereafter referred to as the BRN Biospecimen Contributing Institution (BCI), to collect, process, and annotate post-surgically removed tissue and blood biospecimens under defined protocols. The BCI will be the first component of a larger multi-center overall plan for biospecimen research as described below. Further, the goal of this research is to systematically analyze the effects of biospecimen pre-analytical variables on molecular analysis. To this end, up to 1200 case-matched tumor and 1200 control samples per subcontract year will be analyzed to achieve a statistically significant dataset for each cancer type in the project. It is anticipated that several hospital centers will be subcontracted over a 5 year period to each produce up to 300 case-matched tumor and 300 control samples per subcontract year. SAIC-Frederick (SAIC-F) will engage with clinical sites capable of meeting the case accrual rates, along with specific protocol, data, and biospecimen requirements of the project. The subcontract(s) that results from this procurement will be designated as a BCI. The collection, processing, storage, and shipment of biospecimens obtained for analysis in the intended research project must be performed under well-documented and rigorously quality-controlled procedures. Intra-operative variables must be well documented and post-operative pre-analytical variables must be thoroughly controlled. Biospecimens must be extensively annotated with regard to acquisition and processing variables, beginning with intra-operative and post-operative variables. Electronic histologic images must be provided for the purposes of pathology verification. The hospital subcontractors must ensure that only the highest quality biospecimens are obtained. It is important to note that "high quality" refers not only to biological quality of the samples (i.e., histological and molecular integrity) but also to the related clinical annotation and the status of ethical and legal documents associated with the samples (i.e., institutional review board [IRB] protocol review, appropriateness of the informed consent process, and presence or availability of material transfer agreements [MTAs]), the quality of the associated data (i.e., the extent of donor clinical and biospecimen annotation), and the degree of process documentation (e.g., sample handling and storage protocol detail, QA and QC). It is essential to this research that any variation in molecular analysis data be traceable to the handling variables or intrinsic biologic differences between biospecimens, rather than to undocumented variations in biospecimen handling protocols or other technical/operator differences. In actual execution, the work performed under this subcontract will resemble a complex clinical trial with all the appurtenant human subjects protection, study and cohort management, and data collection issues, layered on top of stringent workflow and laboratory protocols required for the collection of biospecimens of high biological quality. Subcontracted BCIswill be expected to view this statement of work as a clinical trial in which the purpose of the protocol is to collect and process biospecimens under defined experimental conditions.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=920c6f96be3efa42f5e58cc2ace1267b&tab=core&_cview=1)
- Place of Performance
- Address: Subcontractors Location, United States
- Record
- SN01809755-W 20090507/090505222133-920c6f96be3efa42f5e58cc2ace1267b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |