SOURCES SOUGHT
A -- NIDA Data and Statistics Center
- Notice Date
- 12/16/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SBSS-12-003
- Archive Date
- 2/1/2012
- Point of Contact
- Joseph A. TamLung, Phone: (301) 443-6677, Kenneth E Goodling, Phone: (301)443-6677
- E-Mail Address
-
tamlungja@mail.nih.gov, kg25d@nih.gov
(tamlungja@mail.nih.gov, kg25d@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources under the six task categories defined below; (2) whether the capable organizations are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method(s), including whether a set-aside in a specific category is possible. Any qualified organization under the applicable NAICS code may submit a response to this notice. Organizations must have the capability to perform the following task categories: A. Background Information The National Institute on Drug Abuse (NIDA) was established in 1974, and in 1992 it became part of the National Institutes of Health, Department of Health and Human Services. NIDA's mission is to "...lead the Nation in bringing the power of science to bear on drug abuse and addiction." NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction. NIDA-supported science addresses the most fundamental and essential questions about drug abuse, ranging from the molecule to managed care, and from DNA to community outreach research. NIDA is currently seeking systems for data management, statistical support, document management and information technology support and services. The systems will provide an enterprise-wide architecture for NIDA's Information Technology needs. The systems will be used to support data analysis, information exchange, scientific discovery efforts and clinical evaluation of promising new anti-addiction therapies and companion behavioral interventions in order to further NIDA's mission. 1. Clinical Trial Support (Category 1) NIDA conducts single and multi-site clinical trials through grants, contracts and cooperative agreements in sites located across the nation. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. Actual clinical trials will not be conducted under this contract. Activities will support the trials carried out under cooperative agreements or other funding mechanisms. Some of the requirements include: a. Clinical Trial Management i. Establish and administer electronic and web-based systems for the collection, management, and storage of study data; ii. Review and monitor the quality of study data; perform ongoing data checks and data error resolutions; iii. Provide support for protocol development including creation of electronic Case Report Forms; iv. Establish and maintain an electronic and web-based system for monitoring multiple trial progress in near real time, with password protected access, pertinent documents, parameters to be determined by NIDA from its current web-based system; v. Provide input to NIDA's Clinical Coordinating Center(s) that will help identify issues to be pursued during site visits, and that will facilitate the monitors' data verification efforts. vi. Coordinate with the NIDA's Clinical Coordinating Center(s) and study teams. b. Statistical Design and Analysis In collaboration with lead Investigators, develop the statistical sections of the protocols, including study design, randomization and stratification methods, power and sample size calculations, and plans for interim and final data analyses Prepare interim reports for each clinical trial's Data and Safety Monitoring Board and for NIDA. The organization will work closely with lead Investigators and NIDA in the performing of final statistical analyses, the reporting of trial results and the preparation and writing of scientific reports and manuscripts for publication. 2. Document Management System (Category 2) NIDA needs a FISMA compliant, web-based application that constitutes a core service for document management, virtual team collaboration, information retrieval, and business process automation. The application would need to support at least 600 individual password protected users across the United States and territories (and possibly other countries) and more than 60 GB of unstructured data (currently comprising MS Word documents, MS Excel Spreadsheets, Powerpoint presentations, pdfs, etc.) The application must accommodate the functionality for external communications needed to allow off-site Government and non-Government collaborators, contractors and grantees to upload, retrieve and collaborate on documents, data and reports to the system. The system must allow passing documents behind and through the NIH Firewall. The ideal solution would be accomplished with a commercial off-the-shelf (COTS) application or COTS software packages with minimal customization to allow interoperability between programs. NIDA currently uses Livelink from Open Text as its document management and knowledge management tool. The successful solution must be able to accomplish the successful transfer/migration of those files contained in Livelink into whatever application solution is proposed. Coordination and collaboration with other organizations may be necessary to ensure compatibility with other data systems in use by NIDA. 3. Data Management System (Category 3) a. Data Repository NIDA needs a logical (and sometimes physical) partitioning of data where multiple databases that apply to specific applications or sets of applications can reside. The repository must be able to accommodate legacy (historical) clinical trial data, and legacy pre-clinical data, that is currently stored, as well as data from future studies. The solution must permit the incorporation of data from several clinical data acquisition centers that collect and consolidate data from single or multi-center clinical projects Organizations must be able to provide all standard clinical data repository activities including: i. Defining additional requirements, ii. Designing, building, implementing, testing and maintaining the repository, iii. Analyzing source systems for additional data feeds, iv. Consulting in the development of clinical data system standards, v. Collaborating in the development of system interfaces to the repository, vi. Executing, incremental data loads to the repository from protocol-specific source systems and other study management systems. The environment must allow scientific data archiving to ensure that the integrity of, and access to, the data remains available over time to support data sharing efforts. Coordination and collaboration with other organizations may be necessary to ensure compatibility with other data systems in use by NIDA. b. Data Warehouse NIDA needs a "Data Warehouse" that transforms information from clinical trials, including all legacy data, to the form of a relational database that will allow web or text mining to transform or aggregate it into useful information for research. In addition, the "Data Warehouse" must be capable of accepting data from outside sources (i.e. grantees, other contractors, collaborators, etc.). It is anticipated that data from these sources would come from uniform data capture instruments and/or would comply with the central data dictionary. Having the ability to retrieve and analyze data, to extract, transform and load data, and to create/manage a central data dictionary are considered essential features of the system. The warehouse will normalize clinical trial data to permit cross study data analyses down to the individual variable level. In addition, organizations should have the ability to analyze data on the behalf of NIDA by performing analyses on individual study datasets or on individual study variables across studies (Meta-analyses.) Data are expected to move from the data warehouse to the data repository once data are normalized. Coordination and collaboration with other organizations may be necessary during protocol development of clinical trials (see 1.a.iii) as well as after data collection to ensure compatibility with other data systems in use by NIDA. Coordination and collaboration with other organizations may be necessary to ensure compatibility with other data systems in use by NIDA. c. Data sharing To ensure that future research can build on previous efforts and discoveries, the National Institutes of Health (NIH) has developed a data sharing policy that expects final research data, especially unique data, from NIH-supported research efforts to be made available to other investigators. Data sharing applies to human subjects and laboratory research. In some instances, it may include data not produced with NIH funding but used in an NIH-supported activity. In order to be compliant with this policy, and provide access to NIDA clinical trial data, NIDA needs a controlled, secure environment in which eligible researchers can access, request, and obtain clinical trial data in formats that will facilitate various analyses using those data resources. The organization will create a data mart(s) which will allow for the creation of customized clinical datasets that accommodate researcher data analysis requests. Coordination and collaboration with other organizations may be necessary to ensure compatibility with other data systems in use by NIDA. 4. Research Support Application Development (Category 4 ) Occasionally NIDA will have a need for the development of a software solution to support data analysis aspects of its pre-clinical, and clinical, research and development programs. The ideal solution will be accomplished with Commercial Off-The-Shelf (COTS) software or with COTS software packages with minimal customization to allow interoperability between programs. The solutions should be able to operate as stand-alone programs that are easily maintained. a. Engage in requirements gathering with NIDA staff and/or external users b. Provide an analysis of the scope of development (Scope Document) c. Program the code d. Ensure compliance with NIH software policies (including FISMA). e. Beta-Test the program f. Document the internal design of the software for the purpose of future maintenance and enhancement throughout development process. g. Deploy the software h. Provide training and support An example of such a system would be a Pre-clinical compound Evaluation and Tracking System that would allow for the incorporation of clinical structures and clinical, pharmacological and toxicological information into an easily searchable database. The system is utilized to review and compare compounds to determine their potential to be developed as addiction medications. The solution will also include the ability to authorize and track shipments of compounds to contract research laboratories and allow relevant reports and scientific information to be incorporated and linked to a specific compound. 5. Consultant Support (Category 5) a. Support for EHR/EMR Project Provide a variety of support for medical record development for a consensus-based, standardized core set of common data elements (CDEs) on drug use disorders to support clinical decision support, clinical performance measures, and interoperability in vendor electronic (EMR) products and SUD clinical research. NIDA's efforts to develop CDEs for substance abuse have been directed first to developing a hierarchy for domains, subdomains and core questions, which have then been reviewed at workshops and symposia to obtain feedback by experts in clinical care and clinical research across a broad range of stakeholders in the federal government, state government, community treatment providers, large health care providers, primary and specialty care practitioners as members of various professional organizations, and vendors of electronic medical record products. Future efforts will likely follow similar lines, but may require efforts to field test the proposed EMR or CDEs. Coordination and collaboration with other organizations may be necessary to ensure compatibility with other systems in use by NIDA. b. General Consultant Services Provide general IT and scientific consultation, across various disciplines in areas such as development of best practices, design of pre-clinical and clinical studies, identification of scientific gaps and medication development. 6. Information Technology Hardware and Infrastructure Support and Maintenance (Category 6) Organizations shall be responsible for the following: a. Provide technical support to NIDA in the areas of database and systems infrastructure for the development and production environments according to established NIH enterprise architecture standards, policies, and procedures. b. Provide technical support to guarantee the performance, reliability, scalability, availability, manageability, security and recoverability of servers, firewalls, networking components, workstations, software, Oracle databases and applications in the development, production or staging environments. c. Develop and maintain a Vulnerability Assessment Methodology to clearly define system and application vulnerabilities and methods undertaken to test and assure acceptable risk management strategies are employed to minimize threats to the availability and unauthorized access to NIDA information assets. d. Provide technical support to the development environment located at the organizations site and the production and staging environments located at NIDA. e. Interface with NIDA-IRMB, NIH-CIT, and NIH-ATDP to perform administration and maintenance of the NIDA CISCO firewall and the NIH Perimeter firewall in the production environment. f. Provide a disaster recovery strategy, along with its corresponding SOPs, where all project servers are fully backed up to tape media. g. Supplement the tape backup strategy, along with its corresponding SOPs, with the use of server snapshot software, which takes and archives snapshots of the project servers. h. Configure all severs and networking equipment with redundant fail-over hardware components. i. Remotely monitor and manage the development and production environments. j. Provide database administration support to ensure the performance, reliability, scalability, availability, manageability, security and recoverability of the engagement's development and production databases. k. Provide all-aspects of database administration, configuration and support to the project team during the design, development, testing, and implementation and maintenance stages of the application. l. Provide technical support to guarantee availability of all systems and Oracle databases in the development, production and staging environments during the specified hours of operations. m. Provide expertise to project teams with regards to design, procurement, testing, implementation and maintenance of complex, high-availability infrastructure architectures. Similarly, evaluate and respond to new architecture proposals and assists in defining technical requirements and design decisions for custom applications, based on applicable guidelines and best practices. n. Utilize specialized monitoring tools to ensure the performance, reliability, scalability, availability, manageability, security and recoverability of the development and production environments. o. Perform daily server, networking and database maintenance in the development and production environments. p. Maintain an IT infrastructure control and compliance methodology. q. Provide support for software currently used by NIDA and its contractor to meet the general requirements of the support requested. The established NAICS code is 541712. 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 similar projects in the area(s) specified above and work in the field of drug abuse; 2) Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions; and 3) Facilities: Availability and description of facilities and equipment required to conduct the type of work required under a specific task area. 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 under any or all of the task areas. 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 IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. Interested organizations presenting a capability statement must provide the following: 1) company name, address and DUNS number; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes, 5) business size and status; 6) a statement as to which task area(s) the company is submitting information under and the capability information in response to that/those requirement(s); and 7) small business classification. Please submit written capability statements by January 17, 2012 to the NIDA Contracting Officer.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SBSS-12-003/listing.html)
- Place of Performance
- Address: n/a, United States
- Record
- SN02640758-W 20111218/111216234238-0fa42224f080cf4a15decaa6cc49942b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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