SOURCES SOUGHT
A -- NHLBI Clinical Trials Research Network for the Prevention and Treatment of Acute Lung Injury Clinical Coordinating Center
- Notice Date
- 1/25/2012
- 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 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
- HHS-NIH-NHLBI-SBSS-HR-14-01
- Archive Date
- 5/18/2012
- Point of Contact
- Scott A. Bredow, Phone: 301-435-0333, Marianne DiSomma, Phone: 301-435-0369
- E-Mail Address
-
bredowsa@nhlbi.nih.gov, marianne.disomma@nih.gov
(bredowsa@nhlbi.nih.gov, marianne.disomma@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business 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 small business sources; (2) whether they 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, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as the Clinical Coordinating Center (CCC) for a new seven-year program, the NHLBI Clinical Trials Research Network for the Prevention and Treatment of Acute Lung Injury (Network). The Network will develop and conduct randomized controlled clinical trials to prevent, treat, and/or improve the outcome of patients with or at risk for Acute Lung Injury (ALI). More than one trial will be conducted simultaneously and it is expected that multiple, complex trials will be completed during the course of the contract. The emphasis is expected to be on prevention and early treatments. The Network will consist of approximately twelve Clinical Centers (CCs), each with at least one other recruiting site, and a CCC. Each CC will have two principal investigators from one institution that represent (1) an intensive care unit clinician and (2) another clinical investigator, such as an emergency department clinician, with early access to patients at risk for lung injury. The CCs shall also include at least one other institution that will participate in enrollment and study conduct but not network leadership. Each CC will be expected to enroll a total of 220 subjects over 5 ½ years of a seven-year project. The CCC will coordinate all aspects of the research and communication within the Network, including development of protocols, management and analysis of data, assurance of data quality, and statistical and clinical leadership. The CCC will be responsible for collecting and archiving biospecimens during the contract, and depositing the specimens in the NHLBI biorepository at the end of studies. The CCC will be expected to provide the technical leadership to advise the steering committee on the potential and proper techniques for biospecimen collection from critically ill patients that will be useful in developing longitudinal molecular phenotypes. This may be achieved by a subcontract to a commercial or academic entity. Research conducted by this Network should utilize the most modern and flexible electronic data collection, transfer, decision support, and monitoring. Members of the Network will be encouraged to participate in a collaborative Institutional Review Board program to reduce the time and redundancy of protocol approvals and monitoring. As this is developed, the CCC will be responsible for communication with the Network of CCs. Project Requirements The CCC is expected to fulfill the following: 1)Experienced and highly competent in the coordination of complex studies involving critically ill patients. 2)The PI of the CCC will have demonstrated expertise and leadership in biostatistics and clinical trial design and conduct in critically ill patients. 3)The CCC co-investigator will have demonstrated experience in clinical trials and be certified and actively involved in the care and study of pulmonary and critically ill patients, especially Acute Lung Injury. 4)Prepare final protocols for review by the Protocol Review Committee (PRC) and the Data and Safety Monitoring Board (DSMB). 5)The CCC will develop plans for: a.randomization of subjects, b.preparation and distribution of protocols, manuals and forms, c.data collection, quality, completeness, confidentiality, and analysis, d.training of the CCC and the CC staff in implementing protocols and data entry, e.methods to audit site data accuracy and quality, f.preparing and reporting of data and protocols to the SC, PRC and DSMB, g.coordinating drug blinding and distribution, as necessary, h.assisting with the development of efficient Institutional Review Board (IRB) reviews by the many CCs, i.monitoring content of and IRB approval of informed consent forms, j.assisting in preparation of final manuscripts of primary studies, k.coordinating communications among the CCs and scheduling conference calls and meetings of trial committees, as needed, l.organizing (and PIs will attend) meetings of the PRC and DSMB, 6)Experienced in working with the FDA to obtain approvals for new drugs and/or devices. 7)Responsible for developing a plan to lead biospecimen collection by sites and storage at a central lab. 8)Responsible for leading the CCs in the development of a more efficient IRB review process. This could be a collaborative IRB, a central IRB or some other method that will increase efficiency of trial reviews while maintaining safety and quality. 9)Collaborate with the CCs to develop and distribute an Operations Manual detailing procedures for a) collection of data, entry, and transmission of data to the CCC and b) data quality control/assurance procedures. 10)Develop Section 508 compliant computer systems and software needed to collect clinical data at the bedside, to transfer clinical data from the CCs to the CCC, and for storage, retrieval, and statistical analysis of data. 11)Develop and operate a Section 508 compliant randomization system for each trial to ensure equal and unbiased distribution of patients into treatment groups. 12)Develop Section 508 compliant Network web sites (public and internal for the network) that include, but are not limited to, a) a description of the Network objectives, organization, procedures, protocols, and references to publications resulting from Network research trials and b) a link to the NHLBI public web site. 13)Maintain and enhance the Network web sites including a portal for outside investigators to submit research ideas and comments. 14)Plan and coordinate meetings and teleconferences of the SC, PRC, DSMB, and subcommittees as may be necessary. 15)Develop a tracking system for the CC IRB submission and review. As available, review each CC's IRB-approved consent form for adherence to required elements. Maintain a file of the most current consent form from each CC. Ensure receipt of the CCs' IRB approvals for each protocol and for annual reviews, as necessary. 16)Conduct scientific site visits and data quality/chart review site visits. 17)Provide data sets to the SC for preparation of publications of main trial results. Conduct statistical analyses of main trial results. 18)Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/resources/deca/policy.htm Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Scott Bredow, Contracting Officer, at bredowsa@nhlbi.nih.gov and Marianne DiSomma, Contracting Officer, at disommam@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement Indefinite Delivery Indefinite Quantity contract for a period of seven years with an approximate award date of October 3, 2013.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-HR-14-01/listing.html)
- Place of Performance
- Address: 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 RKL2/6016 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02661320-W 20120127/120125235110-0437b48bb6b9769bc2f89587009712fe (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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