SOLICITATION NOTICE
A -- NINDS Center for Clinical Research Data Management, Methodology, Statistical Design, and Quality Control
- Notice Date
- 6/8/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, MD, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NIH-NINDS-06-07
- Response Due
- 7/24/2006
- Point of Contact
- Desiree Wheeler, Contract Specialist, Phone 301 496-1813, Fax 301 402-4225, - Desiree Wheeler, Contract Specialist, Phone 301 496-1813, Fax 301 402-4225,
- E-Mail Address
-
dw76q@nih.gov, dw76q@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institute of Neurological Disorders and Stroke (NINDS) intends to negotiate a follow-on contract with KAI Research, Inc. (PI: Dr. Selma Kunitz), contract # N01-NS-2-2343, awarded 04/01/02) in order to continue to provide support for management with monitoring clinical trials, tracking Institute-supported clinical projects, developing a classification system for research projects and providing methodological support. Background: NINDS ranks as fourth among the NIH Institutes and Centers in the number of ongoing recruiting clinical trials. The NINDS spent in FY 2004 $1.19 billion dollars on 3,423 research projects; of this amount over $372 million dollars (31%) was spent on 769 (22%) projects that required human subjects approvals from an IRG. Of these grants, 47 were designated as phase III clinical trials, and 138 phase I and or II clinical trials, or planning grants for phase III clinical trials. There are currently over 60 DSMB’s that are managed by NINDS program staff, as well as dozens of safety monitoring boards and independent safety monitors that are tracked by staff. In addition to the clinical trials, NINDS also funds 1282 other clinical studies. The Clinical Trial Cluster at NINDS is charged with ensuring the highest quality of each NINDS-funded clinical research project and compliance with DHHS/NIH/NINDS regulations regarding human subject protections and safety monitoring. To accomplish our mission, the NINDS plans to continue work that began several years ago under this contract to provide the Institute and its funded investigators support, oversight, collaboration, and guidance in the conduct of clinical studies. In the past 5 years the activities and responsibilities for this contract have increased substantially. These include the support of new projects, such as SPOTRIAS; the addition of NIH gender and minority data collection for human subject research projects for all NINDS DER; the data tracking system (with the addition of over 300 projects in the past year as well as a substantially increased demand on reporting), and performance of a growing number of site visits to clinical research projects (currently more than double the number initially proposed). The contract renewal will build upon existing activities and architecture and provide support and guidance as future clinical study issues arise. The current Center for Clinical Trial management Resources contract expires at the end of March 2007, and the NINDS intends to negotiate a follow-on contract with KAI Research, Inc. for an additional five years of funding. Based on the experience of this contractor, we expect that the contract will continue to yield outstanding work for the Institute. For the next 5-year contract period, the NINDS plans to continue to implement performance in the following task areas: TASK #1: MONITOR QUALITY ASSURANCE/QUALITY CONTROL IN CLINICAL TRIALS Quality assurance in NINDS-funded clinical trials is the responsibility of the principal investigator and his/her staff. However, the extent of investigators' experience and skill in developing and applying effective quality assurance procedures varies, and some investigators stand to benefit from assistance and guidance received from experts in quality assurance in clinical trials. The overall objective of the quality assurance/quality control performance area is to ensure that the data resulting from a trial are of highest quality and are considered valid and credible within the scientific and clinical community. To assist the investigators in meeting this objective, the contractor shall use its scientific resources to review, monitor, and correct (if needed) quality assurance procedures in NINDS-funded clinical trials. Specifically, the contractor shall: 1. Develop guidelines for investigators and NINDS, specifying the procedures that the investigator should develop and implement to assure data quality and integrity; 2. Provide technical assistance to investigators and NINDS to facilitate the interpretation and implementation of the data quality assurance guidelines; 3. Develop in cooperation with NINDS program staff written procedures for use by the contractor for conducting site visits to review, assess, and correct (if needed) data quality assurance procedures (the initial site visit) and to monitor, assess, and correct (if needed) the implementation and effectiveness of data quality assurance procedures throughout the trial (periodic site visits and the final site visit); 4. Conduct site visits according to the specifications of the procedures document developed in number 3 above. TASK #2: CLINICAL PROJECT TRACKING and MAINTENANCE AND UPDATE OF THE CLASSIFICATION SYSTEM In order to ensure the highest quality clinical research studies and compliance with DHHS/NIH/NINDS regulations regarding human subject’s protections and safety monitoring, accurate and up-to-date information on the status of all clinical research projects supported by NINDS is needed. To facilitate the oversight process, the contractor shall be responsible for the ongoing development and maintenance of a tracking system for all NINDS clinical research projects. The purpose of this function is to identify and track clinical research projects through their various stages, from initial concept development through application, evaluation and award phases. This readily accessible tracking system will provide rapid reporting of all clinical research projects supported by NINDS. In accordance with NINDS scientific, programmatic and regulatory requirements, the contractor shall develop and continuously update a classification system for categorizing ongoing funded research projects in clinical and basic science related to the development of neurological therapies. The Contractor has access to the NIH IMPACII (Information for Management Planning Analysis, and Coordination) Database, more specifically, the following modules: QVR (Query View Report) System to download grant applications; Population Tracking System to track gender and minority information; and the NINDS Scientific Research Project Database (SRPD) which connects to several National Institutes of Health enterprise-wide databases including IMPACII On-line Transaction Processing Database (OLTP) and the IMPACII Report Database (IRDB). Through having access to the databases described above, the contractor shall be responsible for: 1. Maintaining and updating the existing CLIPS database and the generation of reports. This includes reviewing all new grants for inclusion into the database. 2. Conducting a risk assessment of clinical research projects. 3. Collecting and reporting to the NIH the gender and minority data for all identified projects; the NINDS collects supplemental information that is added to the CLIPS to get a more accurate account. 4. Upon request, provide the customized NINDS CLIPS database that encodes NINDS clinical research project descriptors, the customized data dictionary with both administrative and scientific modules and all data that is used to generate NINDS periodic and ad hoc reports. TASK #3: STATISTICAL AND METHODOLOGICAL SUPPORT The contractor shall provide support and consultation to the NINDS in the area of statistics and clinical research methodology. Specifically, assistance shall be required in the development of statistical and methodological guidelines for prospective applicants and for reviewers; statistical consultation will be needed in evaluating requests to submit applications for large clinical projects; expert advice will be needed to help solve methodological problems in ongoing clinical projects; and occasionally, statistical services will be required to conduct statistical analyses. Additional activities may be needed for the support of special short-term projects to evaluate clinical research design, oversight, and conduct of clinical research. TASK #4: CLINICAL DATA ACQUISITION AND ARCHIVING The contractor shall provide consultation and services in the area of data acquisition and archiving. After the termination of clinical research projects, investigators must decide which study materials will be retained or discarded. For stored study materials, storage site, maintenance of confidentiality, and length of storage must be determined. The contractor shall aid NINDS staff in developing information for investigators about archiving data after closure of a clinical trial. For some past contracts, data currently owned by NINDS requires archiving and analysis. The contractor shall provide services necessary to acquire the data and to store them in an electronic form. TASK #5: SPECIALIZED PROGRAM OF TRANSLATIONAL RESEARCH IN ACUTE STROKE (SPOTRIAS) The contractor shall provide support of the SPOTRIAS data and the quality assurance/quality control of the SPOTRIAS sites. Activities include the review of project and study descriptions, assist in data management and data management systems, data format, and quality control procedures; performance of site visits, assist in the development of common data elements, and provision of ongoing support and review. TASK #6: COMMON DATA ELEMENTS The contractor shall provide support for the development of a core set of common data elements and forms supported by a data dictionary and data elements. Literature searches will be conducted and reviewed, forms developed, consensus of key stakeholders sought, and once consensus is obtain these will be published and updated on the NINDS website. Collaboration with other contractors, grantees or others within and outside the NINDS will be necessary. The NINDS believes that KAI Research, Inc. is the only source that has the prerequisite knowledge and expertise to continue the contract work based on their current experience and work under the contract to date. NINDS requires immediate access to a contractor located close in proximity to be available to all NINDS Program Directors for conference calls, face-to-face meetings, etc. at a moments notice. KAI has consistently demonstrated this ability and it’s in very close proximity to the NINDS locale. KAI Research, Inc.’s familiarity with all ongoing NINDS clinical research portfolios and our infrastructure (specific NINDS/NIH databases) puts KAI, Research, Inc. in the most optimal position to continue to provide the Institute this work in a timely and cost-effective manner without causing substantial time delays or additional cost that would possibly be associated with an open competition to the government. In order for another contractor to proceed at this point, it would cost the government significant additional dollars and major time delays during any sort of transition period. A determination for the use of other than full and open competition has been made in accordance with 41 U.S.C. (c)(1), as set forth in FAR 6.302. KAI Research, Inc. is considered the only source capable of performing the above services for the Government in order to maintain a constant level of consistency, uniformity and continuity of services provided. Inherent duplication of the cost to the Government and unacceptable performance delays make competition for this requirement unfeasible. See Numbered Note 22. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (08-JUN-2006). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 23-AUG-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NINDS/NIH-NINDS-06-07/listing.html)
- Place of Performance
- Address: 6001 Montrose Road, Suite 920 Rockville, MD
- Zip Code: 20852-4801
- Country: USA
- Zip Code: 20852-4801
- Record
- SN01124132-F 20060825/060823224410 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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