MODIFICATION
D -- RECOVERY - American Recovery and Reinvestment Act Office of the Secretary (ARRAOS): RFP ST10-1125 Clinical Trials Repository Design and Development for the Food and Drug Administration (FDA) Comparative Effectiveness Research (CER) Initiative
- Notice Date
- 1/13/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- ST10-1125
- Archive Date
- 2/8/2011
- Point of Contact
- Kimberly A Iman, Phone: (301) 228-4033, Jennifer Thomas, Phone: 301/228-4004
- E-Mail Address
-
imank@mail.nih.gov, thomasjennifer@mail.nih.gov
(imank@mail.nih.gov, thomasjennifer@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SAIC-Frederick, Inc. (SAIC-F) in support of the National Cancer Institute's (NCI) Cancer Biomedical Informatics Grid (caBIG) and the Food and Drug Administration (FDA) intends to solicit proposals under solicitation number RECOVERY - ARRAOS ST10-1125, Clinical Trials Repository Design and Development. The FDA houses the largest known repository of clinical study data, including unique high quality data on the safety, effectiveness and performance of drugs, biologics and devices, both pre- and post-approval. These data are not collected or stored in standardized format and for this reason, cannot be evaluated across multiple studies, products or populations except with great difficulty. The goal of this project is to collaboratively build and use the standards, infrastructure, scientific resources, tools and policies needed to receive process and analyze this clinical study data. The infrastructure and approaches developed because of this project will enable studies of comparative effectiveness and other complex research and evaluation using the agency's vast, but untapped, stores of patient safety and clinical efficacy data. The availability of a data repository for storing, organizing, and extracting scientific data about regulated products in a common "language" or format to support regulatory decision making underpins the success of any broader initiatives to comparatively evaluate product performance. Such a data repository will be developed during this project. At its full capacity, CTR will be a comprehensive clinical trial and population health data repository that facilitates access to and analysis of 21st century data sources (e.g., large quantity digital data that come from new imaging and "omics" technologies), and collation of that data with other sources of information on medical product effectiveness, safety, and quality. CTR will be interoperable with clinical data sources such as electronic health records and other data sources and will include protocols for secure and reliable data storage and access, as well as analytic tools for data analysis. The scope of this project is to design and develop CTR and associated services to support the automated processing of datasets compliant with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) from the time they are made available for loading from the FDA's electronic document room (EDR) through their validation and loading into the CTR database. Development of the CTR will include a database design to be developed by the Subcontractor, with such database providing significant analytical and visualization functions. Data marts and SDTM materialized views (SDTM v3.1.2 or later) will be created to facilitate the use of the data for analysis by the FDA reviewers. CTR will be populated with legacy data to operationalize the system for CER. The Subcontractor will identify all requirements for the database and model designs, with consideration for the architecture and infrastructure needed to support a full operational system. The operational system will be developed by working through multiple iterations to design, develop, and test the system, insuring the reference system can be validated when transferred to the FDA. This project will address tasks needed to provide an operational environment that supports the review and analysis of clinical trials data for CER. This operational environment will include the extraction, validation, loading and management of clinical trial data in CDISC SDTM format into CTR. Key objectives are identified in the solicitation package.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/ST10-1125/listing.html)
- Place of Performance
- Address: The majority of the work will be performed at the vendor’s facilities. Periodic meetings and consultations at the FDA and CBIIT offices are expected. Specific tasks, such as testing and demonstrations, will be performed at other locations determined by the SAIC-Frederick, Inc. Contracting Officer’s Technical Representative., United States
- Record
- SN02359518-W 20110115/110113234159-3f9ce599bf3d89c4bdd18651d9d68ebb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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