SOLICITATION NOTICE
D -- RECOVERY - ARROS: ST10-1067 For an initiative called "Janus Infrastructure Development and Implementation for FDA CER" - RFP Solicitation No. ST10-1067 Package
- Notice Date
- 5/6/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541519
— Other Computer Related Services
- 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
- ST10-1067
- Archive Date
- 7/6/2010
- Point of Contact
- Kimberly A Iman, Phone: (301) 228-4033, Gregory M Davis, Phone: 301/228-4011
- E-Mail Address
-
imank@mail.nih.gov, gdavis@ncifcrf.gov
(imank@mail.nih.gov, gdavis@ncifcrf.gov)
- Small Business Set-Aside
- N/A
- Description
- RFP Solicitation No. ST10-1067 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 (including scientific capacity), tools and policies needed to receive process and analyze this clinical study data. The infrastructure and approaches developed as a result of this project will enable pilots 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 warehouse 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. This data warehouse will be developed in the Janus program. At its full capacity, Janus will be a comprehensive clinical trial and population health data warehouse 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. Janus will be interoperable with clinical (i.e., electronic health record) and other data sources and will include protocols for secure and reliable data storage and access, and analytic tools for data analysis. FDA's Center for Drug Evaluation and Research (CDER) (http://www.fda.gov/Cder/) and Center for Biologics Evaluation and Research (CBER) (http://www.fda.gov/CBER/) have been involved in the Janus development initiative since 2006, when the first of several iterative pilot projects for clinical trials data was launched jointly by FDA (http://www.fda.gov) and the NCI (http://www.cancer.gov/) through an Interagency Oncology Task Force (IOTF) (http://biospecimens.cancer.gov/relatedinitiatives/overview/iotf.asp). This pilot, funded primarily by NCI, has gone through several iterations since 2006. Phase 1 of the project, which included requirements gathering, creation of a prototype environment, and implementation of the database as a proof of concept, was completed in January 2006. The Phase 2 operational pilot, which involved integration of two reviewer tools (PhaseForward Lincoln Technologies' WebSDM [http://www.phaseforward.com/products/clinical/ads/default.aspx] and Integrated Clinical Systems, Inc.'s JReview [http://www.i-review.com/index.php]) with the repository, included development of a validation and import facility, loading of validated datasets into the repository, and creation of analytical views (e.g., Study Data Tabulation Model [SDTM] views) to facilitate reviewer access to data maintained in the repository. Following completion of the work on this pilot in March 2007, NCI provided additional "gap" funding so that the team could continue to load SDTM submissions while the planning for the Phase 3 pilot occurred. Phase 1 of Janus resulted in a proof of concept prototype. Janus Phase 2 established an essential architecture and concept of operations for Janus implementation. Phase 3 of the Janus pilot at NCI will include the tasks needed to implement an operational environment that supports the automatic validation, loading, and management of standard clinical trials data in the Janus repository and reviewer access to that data for comparative effectiveness research using the JReview and WebSDM reviewer tools. The requirement of Phase 3 of the pilot at NCI will address tasks needed to transition to an operational environment that supports the review and analysis of clinical trials data for comparative effectiveness research-this operational environment will include the extraction, validation, loading, and management of clinical trial data in CDISC-compliant SDTM format into the Janus repository. Key objectives are to: • Redesign, test, and implement the Janus database based on an updated logical data model that supports improved data integrity, relationships, and analytical functions. This work will include updating the specifications and services required to validate SDTM datasets, populate the Janus database, and create SDTM materialized views. • Develop a "standalone" STDM Validation Service that can be made publicly available to clinical trial sponsors to enable validation of their data sets using the same criteria to be applied by Janus. To accomplish this objective the Subcontractor will develop this service to the level where it has been in production, tested to work with early adopters, and can be easily deployed with appropriate documentation and minimal support. This service will not load data into the Janus repository as it is intended to be used as a preview or check of draft data sets before actual submission to FDA. Once data sets pass the SDTM Validation, sponsors will be able to submit them to Janus via the FDA gateway. • Develop a Load Service to automatically load data sets that are submitted to Janus and "pass" the SDTM validation checks via the integrated STDM Validation service into the Oracle database. An exception handling process for select datasets will be a component of this service. • Continue technical and operational support for the incremental loading and testing of converted legacy datasets or new SDTM datasets concurrently with Janus database redesign activities. This support shall include technical assistance with troubleshooting, handling, and resolving SDTM validation or Janus database load problems and programming support to resolve technical problems in the day-to-day operation of the pilot environment, including data load problems that are not related to data errors. Design, develop, document, and implement processes and procedures to support the operational functions of Janus including workflows and optimized queries to address the need for high volume interactions with the Janus repository. • Analyze requirements, develop, and implement operational enhancements to the Phase 2 pilot architecture, including functional and technical enhancements to the Janus repository database. • Develop requirements, test cases, and testing plans with FDA project managers and adopters and obtain and use specific clinical trial data from across three Centers-the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and some Center for Devices and Radiological Health (CDRH) for testing the system. Develop access management and security functions to allow role-based access to study data (e.g., only FDA reviewers can look at study data associated with a product application, any user can look at de-identified study data, etc.) • Integrate with appropriate caBIG Enterprise services to facilitate completion of all phase 3 Janus requirements and functionality. Service design work will utilize the caBIG® Enterprise Compliance and Conformance Framework (ECCF) documentation. Using these objectives and project descriptions Subcontractor should describe how objectives further the enterprise-level trajectory of development of the Janus repository and will effectively enable the utilizing of the FDA's data on Comparative Effectiveness Research.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/ST10-1067/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
- SN02142508-W 20100508/100506235139-58e648b497c7bcb8ea517a68f3d5c5bc (fbodaily.com)
- Source
-
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