SOLICITATION NOTICE
A -- Pumps for Kids, Infants, and Neonates (PumpKIN) Clinical Trial
- Notice Date
- 12/1/2010
- Notice Type
- Presolicitation
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-12-03
- Archive Date
- 12/24/2010
- Point of Contact
- Roxane Burkett, Phone: 301-594-4588
- E-Mail Address
-
burkettr@mail.nih.gov
(burkettr@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The NHLBI is seeking a small business with the ability to serve as a Data and Clinical Coordinating Center (DCCC) for a new five-year program, Pumps for Kids, Infants, and Neonates (PumpKIN) clinical trials. The purpose of the program is to explore the potential benefit of therapy offered by four novel pediatric circulatory support devices to infants, neonates, and young children (<25 kg) with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse. The trials are intended to provide clinical evidence to be used in Humanitarian Device Exemption applications to the U.S. Food and Drug Administration (FDA) for regulatory approval of the devices. As the PumpKIN DCCC, the contractor will have the overall responsibility for the operation of the trials and will provide the necessary administrative guidance, oversight, and support to achieve the trials’ objectives. The DCCC will be responsible for finalizing the clinical protocols, manual of operations, and monitoring procedures, address other clinical issues, and run the Investigational Device Exemption (IDE) trials according to the planned timeline. One award is anticipated under a Request for Proposal (RFP). The DCCC shall conduct all aspects (administrative guidance, oversight, and support) of the PumpKIN clinical trials. The DCCC shall have overall responsibility for the operation of the clinical trials which includes clinical site coordination, data collection, management, and analyses, and preparation of clinical regulatory documents in support of an Investigation Device Exemption (IDE) clinical trial. The DCCC shall 1) Work with NHLBI to identify competent clinical sites for the trials and finalize subcontracts for the selected clinical sites; 2) Arrange steering committee, protocol review committee, and protocol development committee meetings and arrange data safety and monitoring board activities; 3) Coordinate protocol and manual of procedures writing activities; 4) Develop and distribute clinical trial forms, case report forms, and other reporting tables and figures; 5) Create clinical trial logos, newsletters, brochures, posters, and checklists; 6) Perform clinical regulatory activities including: obtaining research agreements and IRB approvals with each of the clinical sites, monitoring device accountability records by IDE sponsors, obtaining investigator agreements, monitoring clinical sites, informing investigators of plans and study-related reports, and providing clinical reports to the FDA and IRBs (See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046702.htm#resofspofor for further information on IDE responsibilities.) 7) Establish working groups to standardize protocols and establish quality standards for clinical data to be collected; 8) Develop a secure web-based data entry system for data collection and distribution of information to the clinical sites; 9) Develop a training plan and train the clinical site and core laboratories for all aspects of the PumpKIN program; 10) Develop a data analysis plan for the trials and develop a complete data set distribution plan; 11) Manage clinical sites to achieve the goals of the PumpKIN clinical trials. Activities related to this requirement include monitoring patient recruitment, maximizing patient adherence and retention; and auditing the participating clinical sites to maintain quality control; 12) Prepare and distribute technical and statistical reports; 13) Review data to ensure scientific validity and to ensure privacy policies are being properly followed; 14) Organize and maintain IRB approvals, informed consents, and other relevant documents; 15) Collaborate with the FDA by preparing and submitting required reports/data to the FDA; 16) Facilitate communications among all organizational trial components; 17) Maintain the computer system, secure trial database, and software needed for the storage and analysis of all trial data (including biological specimens) collected from all PumpKIN clinical sites and core laboratories; 18) Work with the steering committee to establish a publications and presentations policy and infrastructure for review/prioritization of manuscripts and abstracts; 19) Design and implement a plan for trial closeout, analysis, and dissemination, including final data collection, data transfer (if necessary), verification, analytical support for scientific writing groups, publication of trial results, and plans for the investigators’ dissemination of trial results; and 20) Analyze data and prepare trial reports, create a public dataset and data sharing plan, and create and distribute all final reports to the NHLBI and FDA. This is not a request for proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about December 20, 2010. This advertisement does not commit the Government to award a contract. Original Point of Contact Roxane Burkett, Contract Specialist, NHLBI Extramural Contracts Branch, Phone (301) 435-6671, Fax (301) 480-3432, Email: burkettr@nhlbi.nih.gov Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions 6701 Rockledge Dr RKL2/6125 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HV-12-03/listing.html)
- Place of Performance
- Address: Office of Acquisitions, 6701 Rockledge Dr., RKL2/6125, MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02336709-W 20101203/101201234622-4679b4a1044980eb8ecd423b934a748d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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